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Search Results Within Category "Neurology"

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62 Study Matches

Hand Action and Perception in Parkinsons Disease

The purpose of this research study is 1.) to determine if Parkinson’s Disease (PD) causes changes in the way that people sense the movements of and forces produced by their bodies, and to connect any of these changes in sensation to changes in the brain, and 2.) to identify how changes in movement might come from different parts of the nervous system. This study will use a combination of electromyography, via electrodes placed on the skin, and finger force recordings to infer how PD effects patients' sense of force production, and the neural mechanisms underlying this change.

This study requires a single in-person visit and will use adhesive skin sensors on the forearms to measure muscle activity while subjects press on sensors which record force levels. Subjects will be asked to match force levels between hands and to move an on-screen cursor into a target.

40

Joseph Ricotta
Joe Ricotta - at ricotta@psu.edu
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020063
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Inclusion Criteria:
Persons with Parkinson's disease, age 50-85, or subjects without Parkinson's disease, age 21-85
No history of earning disability, neurodevelopmental disorder, seizures, multiple concussion (> 3), cerebrovascular disease, brain tumor, hydrocephalus, or any CNS disease other than PD.
No present carpal tunnel syndrome, cervical myelopathy, brachial plexopathy, hand pain, or another neuromusculoskeletal disorder affecting hand function
No history of alcohol and/or drug abuse.
Right handedness.

Exclusion Criteria:
History of specialized hand training such as professional musicianship.
Neurology
Not applicable
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Hershey, PA ,

Asymmetries in Cognitive Aspects of Motor Control and Learning

This study will improve our understanding of movement control and how strokes of different sides affect overall independence. Participants will complete the visit seated at a chair with sensors connected to the less-affected arm. They will then play a short virtual reality game and complete several questionnaires and assessments.

Robert Sainburg
Shanie Jayasinghe - at sjayasinghe@pennstatehealth.psu.edu or 717-531-0003, ext=283146
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015871
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Inclusion Criteria:
Right handed (pre-stroke)
Neurological confirmation of unilateral stroke
Severe paresis on one side only
Adults over the age of 18
Chronic stage of stroke (>3 months post stroke)

Exclusion Criteria:
Left-handed (pre-stroke)
Neuro radiological confirmation of extensive periventricular white matter changes
History of neurological diseases other than stroke
Significant joint pain that is activity limiting
Neurology
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Hershey, PA ,

Characterizing the Visual Pathway in Epilepsy

This research is being done to determine whether the way your brain processes vision is involved in the epilepsy disease process. There has been recent evidence suggesting that epilepsy patients, compared to healthy controls, have thinner retinas, specifically a layer called the retinal nerve fiber layer, the inner most layer of the retina. This study will expand on that finding by investigating any differences in all of the retinal layers, as well as visual function, between epilepsy patients and healthy controls.

Vinita Acharya
psniclinresearch@pennstatehealth.psu.edu 717-531-8521
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011054
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Inclusion Criteria:
All: 18-65 years of age
Patients only: Clinical diagnosis of epilepsy

Exclusion Criteria:
All: Those who cannot complete the eye scan or visual tests
All: Those who have diabetes
All: Those who have glaucoma
Neurology, Vision & Eyes
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Hershey, PA ,

Physical Therapists Role in Promoting Physical Activity for People with Chronic Physical Disabilities

We plan to conduct a qualitative study exploring perspectives of physical therapists and people with disability regarding physical activity promotion

Jacob Corey
Jacob Corey - at jjc6062@psu.edu or 814-865-1691
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00012768
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Inclusion Criteria:
At least 18 years of age
Fluent in english
Individual with a physical disability (eg. limb amputation, spinal cord injury, spinabifida, cerebralpalsy, arthritis, motor impairment)
Has participated in physical therapy in the last year

Exclusion Criteria:
Under the age of 18
Does not speak fluent english
does not have a physical disability
Has not participated in physical activity in the last year
Arthritis & Rheumatic Diseases, Neurology, Muscle & Bone
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Prion Disease Registry at Penn State Health

This research is being done to help us better understand prion disease. The goal of the study is to establish a registry of patients with rapidly progressive dementia, suspected prion disease, or confirmed prion disease. A disease registry is an extensive collection of data related to patients with a specific diagnosis that plays an important role in the surveillance of a disease. Prion disease has poor prognosis, yet there is currently no approved treatment. The collection of information from prion patients will help us gather information to help advance the study of this pathology and potentially help contribute to treatments and preventative methods in the future.

100 participants in the prospective study and 100 participants in the retrospective study, aged 18 and up who meet the inclusion criteria for this study who have obtained informed consent will have standard of care data be collected at their initial visit, such as vital signs and laboratory tests for example. During follow-up visits, standard of care data will also be collected again for the registry. Patients will come to their scheduled visits until they withdraw or die.

Joseph Nguyen
psniclinresearch@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00017081
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Inclusion Criteria:
Aged 18 or older
Diagnosed with prion disease
Suspected prion disease
Rapidly progressive dementia

Exclusion Criteria:
Aged less than 18
Without diagnosis of or suspected prion disease, or without rapidly progressive dementia
Neurology
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Deprexis Study: An online program to reduce depression in MS – a phase III international multicenter randomized controlled trial

An online program to reduce depression in MS – a phase III international multicenter randomized controlled trial

Peter Arnett
Deprexis Team at mhc147@psu.edu or 814-865-5578
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02740361
STUDY00004660
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Inclusion Criteria:
Diagnosis of Multiple Sclerosis
Current Depression
No current treatment for depression
Internet access
Between the ages of 18-65

Exclusion Criteria:
No diagnosis of MS
No current psychotherapy for depression
No substantial neurocognitive impairments
Started anti-depressants in the last 2 months
Neurology, Mental & Behavioral Health
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State College, PA ,

Linking olfactory deficits to memory impairment and AD neurodegeneration

The purpose of this voluntary research study is to find out more about changes in the brain as we age. This study is trying to determine if magnetic resonance imaging (MRI), genetic variations, amyloid positron emissions tomography (PET), neuropsychological testing, and smell tests can be used to evaluate memory loss and cognitive impairment.

You will be asked to come to the research site once a year for 5 years. Annual (and semi-annual) procedures include completing smell tests, neuropsychological tests, magnetic resonance imaging (MRI). One-time procedures include provide blood sample, amyloid PET scan (if indicated), and optional lumbar puncture.

Up to $250 a year

Prasanna Karunanayaka
Rommy Elyan - at relyan@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018557
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Inclusion Criteria:
Individuals between ages 55-85

Exclusion Criteria:
Non-English speaking
Smell impairment
Women who are pregnant or breastfeeding
Currently smoke
Have claustrophobia
Neurology
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Hershey, PA ,

Emotion Regulation and Mother-Infant Synchrony

The aim of this study is to better understand emotion regulation in infants by measuring brain, behavior, and mother-infant relational mechanisms. We plan to collect simultaneous brain activation in mothers and infants while they engage in a face-to-face interaction. We will then test associations between individual brain activation, mother-infant brain synchrony, and infant emotion regulation behaviors.

Participants complete questionnaires online, then come in for 1 in-person visit. Mother and baby complete a play and a neutral task while fNIRS is collected from them simultaneously.

40

Berenice Anaya
Berenice Anaya - at bua25@psu.edu
 

All
All
This study is also accepting healthy volunteers
STUDY00018109
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Inclusion Criteria:
Infants who are 4 months and their mother.
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.

Exclusion Criteria:
Infants who were < 2500 g at birth.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Children's Health, Neurology
Not applicable
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State College, PA ,

Predicting Concussion Outcomes with Salivary miRNA

The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows: 1) Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years. 2) Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.

Andrea Loeffert
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
 

All
All
This study is also accepting healthy volunteers
NCT02901821
STUDY00003729
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Inclusion Criteria:
5 to 23 years of age
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion

Exclusion Criteria:
Does not speak english
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
Children's Health, Neurology, Sports Medicine
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Hershey, PA ,

Eye-hand coordination during upright stance

The study will determine how the brain controls eye and hand movements during quiet upright stance.

There will be one visit to the lab (approximately 2 hours) in which participants will be required to make reaching movements towards virtual targets while standing upright. Participants will be required to wear comfortable shoes.

$20

Tarkeshwar Singh
Tarkeshwar Singh - at tsingh@psu.edu or 814-865-7851
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019952
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Inclusion Criteria:
1) Participants should be between 18-65 years old
3) Participants will be right-hand dominant individuals
4) They will have normal or corrected-to-normal vision
5) Participants should be able to stand upright for long periods (up to 2 and a half hours) with rest every 5-10 minutes or as requested by the participant
6) Participants should be able to grasp a handle and move objects with both hands

Exclusion Criteria:
Any history of neurological disorders (e.g., Parkinson’s disease, Alzheimer’s disease, Multiple Sclerosis)
Any history of musculoskeletal disorders (e.g., carpal tunnel syndrome)
Any history of cardiovascular disease (e.g., Coronary Artery disease, Peripheral Artery disease, Carotid Artery disease, Hypertension, Congenital Heart disease, Congestive Heart failure, Myocardial Infarction, Cardiac Arrythmias, Stroke).
Any history of conditions or diseases that increase risk for syncope (e.g., Anemia, Myocardial Ischemia, Kidney disease).
Any history of conditions or diseases of the vestibular system
Neurology, Vision & Eyes
Not applicable
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State College, PA ,

A Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas

This research is being done to understand how much of two drugs (dabrafenib and trametinib) is able to enter brain tumors and how well the drugs are able to turn off this pathway in brain tumors. The study will also look at how tumors lose sensitivity to this treatment. People with primary brain tumors who are already taking dabrafenib and trametinib and who need a brain surgery are eligible for this study. Biospecimens (tissue, blood, and cerebrospinal fluid (CSF)) taken during the surgery will help us understand how much of these two study drugs actually get into the brain, their effect, and how the tumors become resistant to treatment.

Michael Glantz
psniclinresearch@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010083
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Inclusion Criteria:
At least 18 years old
Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician.
Subjects must be undergoing surgery for clinical purposes

Exclusion Criteria:
Younger than 18 year old
Subjects who are receiving any other investigational agents or chemotherapeutic agents.
Neurology, Cancer
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Hershey, PA ,

Regional Brain Manganese Accumulation and Functional Consequences in Welders

Inhalation of welding fumes has been known to cause tremor, muscle rigidity and abnormal gait similar to what is seen in Parkinson's disease. Previous studies by the Translational Brain Research Center have used measures such as brain MRIs and tests for movement and function to investigate the effect of these welding fumes on brain health in active welders. The center is currently expanding its efforts to investigate brain health in retired welders. This is an independent study sponsored by the National Institute of Environmental Health Sciences, with no affiliation to any private entities such as law firms. In this study participants will be asked to undergo clinical tests (blood draw, motor examination, memory tests), complete lifestyle questionnaires, and undergo an MRI scan during a baseline and 18 month follow-up visit. Participants also will be mailed a welding exposure questionnaire to complete every three months between their baseline and follow-up visit.

Participants will attend a screening call with the study team, an in-person baseline visit and an in-person follow up visit (at 18 months). Participants will complete questionnaires, undergo clinical tests (blood draw, motor evaluations, memory tests), and undergo MRI scan. Participants will also have the option to complete mobile phone assessments and undergo four skin punch biopsies.

Up to $750 per participant

Xuemei Huang
Amanda Snyder - at TBRC@pennstatehealth.psu.edu or 717-531-5233
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00005467
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Inclusion Criteria:
Active or retired welder (e.g., boilermaker, pipefitter, etc.)
No obvious signs of parkinsonism (e.g., tremor, impaired speech)
Fluent in written and spoken English
No metal eye fragments
Able to tolerate a brain MRI

Exclusion Criteria:
Severe memory impairment or signs of dementia
Claustrophobia or unwillingness to undergo an MRI
Significant medical and neurological deficits (e.g., brain tumor, seizures, stroke, etc.)
Significant recreational drug use or alcohol abuse
History of chronic paint and solvent exposure
Neurology
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Hershey, PA ,

Site for Refinement of a rapid saliva miRNA diagnostic test for concussion

The purpose of this research is to use saliva swab as a tool to diagnosis concussions and be able to differentiate a concussion and other medical conditions with the similar symptoms.

During their baseline visit participants will complete a saliva swab &amp; surveys. Day 7, participants will complete a saliva swab and 2 surveys. Day 30, participants will complete a saliva swab and 4 surveys. The baseline visit is the only in-person visit, day 7 and day 30 are done remotely. All surveys are completed online and day 7 and day 30 saliva swabs are sent home with the participants and sent back in a prepaid mailer on day 30.

$20

Andrea Loeffert
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
 

All
All
This study is also accepting healthy volunteers
SITE00000814
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Inclusion Criteria:
13-22 years old
Diagnosis of concussion

Exclusion Criteria:
< 72hrs after TBI
Children's Health, Neurology, Sports Medicine
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Hershey, PA ,

Monetary Reward Processing and Emotion Regulation in Adolescence: An fMRI pilot Study

This research is being done to identify patterns of brain activation underlying monetary reward processing and emotion regulation in adolescence, as well as correspondence between parent and adolescent neural activation. Children and their parents will complete questionnaires. Children will complete computer tasks during EEG and in an MRI scanner. Parents can also complete the MRI scan if interested.

Dara Babinski
Michael West - at ABC@pennstatehealth.psu.edu or 717-531-0003, ext=285968
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00008393
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Inclusion Criteria:
Ages 12--16 years
Fluent in English
No history of treatment for psychiatric disorders

Exclusion Criteria:
Intellectual or developmental disabilities
Visual or hearing impairments
Inability to complete MRI scan due a pacemaker, aneurysm clips or any metal in body (e.g., braces, surgical devices)
Currently pregnant or lactating
Neurological disease (e.g., stroke, tumor, Parkinson’s disease, etc.)
Children's Health, Neurology, Mental & Behavioral Health
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Hershey, PA ,

Home telemonitoring of bulbar function by acoustic measurement of swallowing and speech sounds in ALS

Most individuals with ALS experience changes in speech and swallowing over the course of the disease. In some, these are their initial indication of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery. This is a longitudinal home study of ALS patients to assess speech and swallowing function through use of smartphone application. The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS. Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on their cellphone. Healthy controls will be enrolled to judge the intelligibility of speech samples provided by patients in the study.

Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on a cellphone.

340

Andrew Geronimo
Cristie Crawford - at ccrawford5@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04889898
STUDY00016872
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Inclusion Criteria:
At least 18 years of age
Possess a diagnosis of amyotrophic lateral sclerosis (ALS)
Have symptom onset within the last 3 years
Demonstrate changes in speech or swallowing as a result of ALS.
Possess a smartphone capable of running the study application or have home wireless internet service capable of transmitting study data from a study-issued smartphone.

Exclusion Criteria:
Possess a co-existing neurological or psychiatric illness in addition to their ALS diagnosis
Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
Neurology, Language & Linguistics
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Hershey, PA ,
State College, PA ,

RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy

This is a multi-site, placebo-controlled, double-blind, time to intervention study designed to evaluate the clinical efficacy and safety of droxidopa versus placebo over a 12-week double-blind treatment period in patients with symptomatic NOH who have previously received up to 16 weeks of open-label treatment with an individually optimized dose of droxidopa (randomized withdrawal design).

Divpreet Kaur
Anne Haulman - at ahaulman@pennstatehealth.psu.edu or 717-531-0003, ext=289123
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02586623
STUDY00006945
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Inclusion Criteria:
Symptomatic neurogenic orthostatic hypotension associated with: (1) primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, Pure Autonomic Failure), (2) Non-Diabetic Autonomic Neuropathy, or (3) Dopamine Beta Hydroxylase deficiency
Able to stand, with or without limited assistance

Exclusion Criteria:
History of heart attack within the past 2 years, congestive heart failure (class 3 or 4), or uncontrolled cardiac arrhythmia
High blood pressure that requires treatment with blood pressure medication
History of cancer within the past 2 years (some exceptions can be discussed)
Diabetic autonomic neuropathy
Women who are pregnant or breastfeeding
Neurology
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Hershey, PA ,

Muscular Dystrophy Association Neuromuscular Observational Research (MOVR) Data Hub Protocol

The Muscular Dystrophy Association (MDA) wants to collect information about individuals with neuromuscular disease to better understand the disease progression and ultimately improve the medical care, quality of life, and survival of those with neuromuscular disease. To collect this information, MDA has created a data registry called the Neuromuscular Observational Research Data Hub (referred to as the “MOVR Data Hub”). The MOVR Data Hub is a kind of database — a way of collecting and storing information.

Each person who participates in the MOVR Data Hub will have his/her information collected for as long as the person is being seen at an MDA Care Center and information is still being collected, unless and until the person requests that the information no longer be provided to the MOVR Data Hub.

Mansoureh Mamarabadi
Cristie Crawford - at ccrawford5@pennstatehealth.psu.edu or 717-531-0003, ext=322992
 

All
All
This study is NOT accepting healthy volunteers
STUDY00012883
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Inclusion Criteria:
Diagnosed with a neuromuscular condition

Exclusion Criteria:
Unwilling to provide informed consent
Neurology
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Hershey, PA ,

Atrophy of Olfactory Bulb in Early-stage Parkinson’s disease

This research is being done to study the deterioration of the central olfactory system (sense of smell system) in the brains of patients diagnosed with early- stage Parkinson’s disease.

Jian-Li Wang
Jianli Wang - at jwang2@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00005422
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Inclusion Criteria:
A physician-documented parkinsonian symptom onset between the ages of 40-59 will
Patients should not have reached their 65th birthday.
Patients that have tremor, rigidity, and bradykinesia unilaterally

Exclusion Criteria:
Dementia
Autonomic dysfunction
Parkinson-plus syndrome
Postural instability
History of exposure to substances that cause parkinsonism
Neurology
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Hershey, PA ,

A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

The main purpose of this research study is to test whether an experimental drug called edaravone, is effective as treatment against ALS, and if it is safe and well tolerated when given to patients with your illness. The study will compare the efficacy and safety of an oral form of edaravone (a liquid solution that you will swallow) when given in 2 different ways.

There will be a total of 16 visits over the course of 1 year. 8 of these visits will be in person in our clinic. At these visits, blood tests and breathing tests will be required.

James Grogan
psniclinresearch@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04569084
STUDY00016396
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Inclusion Criteria:
Age 18-75
Diagnosed with amyotrophic lateral sclerosis (ALS)
Forced vital capacity (FVC) ≥ 70% predicted
Symptom onset within the past 2 years

Exclusion Criteria:
History of spinal surgery after the onset of ALS
Currently undergoing treatment for cancer
Hereditary fructose intolerance
Any previous treatment with edaravone
Neurology
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Hershey, PA ,

Asymmetric neurodegeneration of central olfactory system in early-stage Parkinson’s disease

This research is being done to study the deterioration of the central olfactory system (sense of smell system) in the brains of patients diagnosed with H&amp;Y stage 1 or 2 Parkinson’s disease compared to that of healthy volunteers.

Jian-Li Wang
Lauren Spreen - at lspreen@pennstatehealth.psu.edu or 717-531-5857
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00005378
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Inclusion Criteria:
Cognitively-normal H&Y stage 1 PD patients. A physician-documented parkinsonian symptom onset between the ages of 40-59. 1st visit prior to age 65. PD stage I diagnosis must be documented for a min of 2 years.
Cognitively-normal H&Y stage 2 PD patients. H&Y stage 2, as defined by an exam in the practically defined “off” state, and have a diagnosis of PD at the age of 59 or younger. 1st visit prior to age 65
Healthy participants between ages 40-64 at their first visit.
Able and willing to provide informed consent
Fluent in written and spoken English

Exclusion Criteria:
Parkinson-plus syndrome
Dementia
Previous antipsychotic or anti-dopamine drug therapy
Traumatic head injury
Other neurological diseases or disorders
Neurology
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Hershey, PA ,

Defining the role of slow eye movements on limb motor control

The purpose of the study is to examine how slow eye movements called smooth-pursuit eye movements, contribute to hand-eye coordination. Participants will grasp a robotic manipulandum and using the manipulandum interact with virtual visual stimuli in an augmented-reality environment.

Tarkeshwar Singh
Tarkesh Singh - at tsingh@psu.edu or 814-865-7851
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018339
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Inclusion Criteria:
Right-handed individuals (males and females) between 18-65 years of age
Should have normal vision or corrected vision
Participants should be able to sit upright on a chair for upto 2 hours
Participants should be able to grasp and move objects with their right hand
Participants should be able to provide informed consent

Exclusion Criteria:
History of neurological disorders (Parkinson’s or Alzheimer’s (e.g., Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease, Friedreich's ataxia, aneurism, brain tumor, epilepsy, suffered a concussion in the last 5 years, TBI, stroke)
History of musculoskeletal disorders (e.g., carpal tunnel syndrome, arthritis, fibromyalgia, tendinitis, trigger finger, mallet finger, fracture, or previous injury to the bones or joints in your neck, upper back, arms or hands in the last six months)
eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained.
Medication that could make the participant either drowsy or tired. Individuals who get tired with 2 hours of mild to moderate exercise are also not eligible to participate.
Neurology, Vision & Eyes
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State College, PA ,

Remote pulmonary function testing in amyotrophic lateral sclerosis (ALS)

The specific objective of this proposal is to validate the practice of remote pulmonary function testing (rPFT) through home measurement of breathing function. The central hypothesis is that guided home assessment of breathing function is a valid method for detecting respiratory distress. This study has the potential to transform the current practice of conducting breathing assessments every three months, resulting in timelier detection and management of respiratory distress. The study has two parts. [CLOSED TO ENROLLMENT] The first part is a self-controlled study which will enroll 40 patients from the ALS clinic. On the day of their clinical visit, study participants will perform both a standard PFT with a respiratory therapist and a simulated rPFT. The primary hypothesis is that there is no difference in the results of PFT and rPFT. The second part is a two-arm randomized intervention in 40 patients with ALS. All subjects will perform weekly home respiratory testing for up to a year, and complete questionnaires at regular intervals during this period. Part 2 also incorporates a nurse health coaching component, with subjects randomized to a group that recieves monthly nurse coaching, and one that does not.

Andrew Geronimo
Wint Nandar - at wnandar@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00006924
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Inclusion Criteria:
Possess a diagnosis of amyotrophic lateral sclerosis (ALS)
Be 18 years of age or older.
Have a caregiver available to assist with home PFTs or, in the opinion of the investigator, can perform home PFTs unassisted.
Symptom onset within the last three years.
Have an internet-capable home computer and cellphone.

Exclusion Criteria:
Inability to perform pulmonary function testing with mouthpiece or with mask, as determined by one of the study investigators.
Neurology
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Hershey, PA ,

Site for Identifying the Cognitive, Psychological, and Neuroimaging Signatures of Head Trauma in Female Survivors of Intimate Partner Violence

The overall purpose of this study is to examine the effects of sub-acute and chronic traumatic brain injury (TBI) and hypoxic brain injury (HBI) on neural networks, cognitive, and psychological outcomes in individuals who have experienced intimate partner violence (IPV). Participants will be asked to complete a series of cognitive tests and a brain imaging scan.

The study includes interviews to discuss your any experiences you have had with physical abuse and head trauma, as well as current and past mental health history. Then you will complete questionnaires to see how you feel about your mental and physical health, followed by tests to assess your thinking abilities. Finally you will complete a magnetic resonance imaging (MRI) session to examine brain structure and function. All of the testing should take approximately 6 hours to complete.

$90

Frank Hillary
Elizabeth Rebuck - at exr5373@psu.edu or 814-865-0389
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00000844
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Inclusion Criteria:
Female
Aged 18-60
Has previously experienced intimate partner violence

Exclusion Criteria:
Male
Currently experiencing intimate partner violence (within the past 3 months)
Non-English speaker
Neurological and developmental disorders
Neurology, Mental & Behavioral Health, Women's Health
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Altoona, PA ,
Hershey, PA ,
State College, PA ,

Predicting Ipsilesional Motor Deficits in Stroke with Dynamic Dominance Model

This study will test the hypothesize that the combination of low-moderate to severe paresis and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.

There will be two evaluation sessions, 15 training sessions, and 3 post-test evaluation sessions

$2,100

Robert Sainburg
Candice Maenza - at CMaenza@psu.edu or 717-531-0003, ext=283146
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03634397
STUDY00008385
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Inclusion Criteria:
Over the age of 18
Motor impairment in the arm
Had a stroke confirmed by neurology
Chronic stage of stroke

Exclusion Criteria:
neurological disease other than stroke
a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder)
hospital admission for substance abuse
peripheral disorders affecting sensation or movement of the arms,
currently taking prescription drugs with known sedative properties that interfere with sensory-motor function
Neurology
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Hershey, PA ,

Application of graph theory to both resting-state and task-based fMRI data to uncover brain-behavior relationships related to therapy outcomes in aphasia

This project will use fMRI to examine changes in the brain related to behavioral therapy outcomes in persons with aphasia. We aim to recruit twenty persons with aphasia. Each participant will receive 4 MRI scans. Between scan 1 and scan 2, no therapy will be provided (10 week break). Between scan 2 and scan 3, ten weeks of word finding therapy will be provided. Between scan 3 and scan 4, no therapy will be provided (10 week break). The therapy used is abstract word retrieval training. The results of this project will help inform rehabilitation practices in aphasia.

There will be 4 fMRI scans. After the first and third fMRI scans, there will be an assessment. After the second fMRI scan, there will be 10 weeks of treatment.

$460

Chaleece Sandberg
Chaleece Sandberg - at cws18@psu.edu or 814-863-2006
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03550092
STUDY00009502
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Inclusion Criteria:
Diagnosis of aphasia
Sustained stroke at least 6 months ago
Right-handed
Native English speaker
Completed at least a high school education

Exclusion Criteria:
History of neurodegenerative disease (e.g., Alzheimer's)
History of other acquired neurological disorder (e.g., TBI)
History of developmental disorder (e.g., autism)
History of psychological disorder (e.g., schizophrenia)
Unsafe to receive MRI (e.g., pacemaker)
Neurology, Language & Linguistics
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Hershey, PA ,

Site for HEALEY ALS Platform Trial - Master Protocol

The HEALEY ALS Platform Trial is a multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. The trial is designed as a perpetual platform trial. This means that there is a single Master Protocol determining the conduct of the trial.

The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. The following things will happen in this research study: Blood and urine sample collection; Completion of questionnaires; Physical and neurological exams; Vital signs, current and historical review of medical information about general health and medication use review; Muscle strength testing; Measurement of the electrical activity of the heart with an electrocardiogram (ECG); and Measurement of respiratory (breathing) function. Participants will also take either the study drug, or placebo, according to the study schedule

Zachary Simmons
Heidi Runk - at hrunk@pennstatehealth.psu.edu or 717-531-0003, ext=287177
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04297683
SITE00000630
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Inclusion Criteria:
Diagnosed with amyotrophic lateral sclerosis (ALS)
Slow vital capacity (SVC) at least 50% predicted
Time since onset of weakness due to ALS within 36 months
Able to swallow pills and liquids

Exclusion Criteria:
Exposure at any time to any gene therapies under investigation for the treatment of ALS
Clinically significant unstable medical condition (other than ALS) that would pose a risk to you
Neurology
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Long-Term Nicotine Treatment of Mild Cognitive Impairment

The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in people experiencing mild memory problems (referred to in this study as “mild cognitive impairment” or MCI). Recent studies have suggested that one of the causes of memory disorders may be a reduction in a particular chemical substance in the brain. This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps us to remember and use memories as well as affect our attention. In people with MCI (and Alzheimer’s disease), the level of acetylcholine may be changed, and this may impair brain functioning. Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer’s disease (AD). It has been known for many years that nicotine imitates many of the actions of acetylcholine. By administering nicotine over a longer period of time to participants with MCI, we hope to better understand whether nicotine may act to improve memory loss symptoms over the longer term and whether it may help to delay the progression of memory loss symptoms. The amount of nicotine in each patch used in this study is the same as patches that are FDA approved for use in people who are trying to quit smoking.

Subjects will be asked to come to the Penn State Health Milton S. Hershey Medical Center for a screening visit, which will determine eligibility. This visit includes blood work, a urine sample, an ECG, a physical and neurological exam, memory/cognitive tasks, and vital signs. Certain portions can be done remotely via phone. If eligible, subjects will be randomized to wear a nicotine patch or placebo and will complete 11 more visits about once every three months over two years. Some visits are longer than others and are a combination of in-person activities and remote participation via phone. Subjects will be asked to report medication changes and adverse events at every visit.

$600

Paul Eslinger
psniclinresearch@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02720445
STUDY00008978
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Inclusion Criteria:
Patient must have a subjective memory concern as reported by patient, study partner, or clinician
Age 55-90 (inclusive)
Study Partner is available who has frequent contact with the patient (e.g. an average of 10 hours per week or more), and can accompany the patient to most visits to answer questions about the patient
Must speak English or Spanish fluently
Good general health with no additional diseases/disorders expected to interfere with the study

Exclusion Criteria:
Any use of tobacco or nicotine products within the past year
Any significant neurologic disease such as Alzheimer’s disease dementia, Parkinson’s disease, multi-infarct dementia, brain tumor, seizure disorder, etc.
History of alcohol or substance abuse or dependence within the past 2 years
Neurology, Mental & Behavioral Health
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

The impact of COVID-19 on cognitive and neuropathological processes leading to Parkinson’s Dementia and other Alzheimer’s Disease Related Dementias (ADRD)

Our objective is to understand potential factors, such as COVID-19, that influence the development and/or progression of Parkinson’s disease and related disorders. We will engage previous, ongoing, and future Translational Brain Research Center (TBRC) research participants to obtain information regarding exposure, current clinical and functional status, motor/cognitive daily activities, and COVID-19 history.

Participants will be asked to complete several forms, questionnaires, a motor exam, a scratch-and-sniff smell test, undergo optional neuropsychological testing, undergo optional (EMA) mobile phone remote data collection, and complete optional MRI and biosample collection. Also, a subset of subjects with and without history of COVID-19 infection will be invited for an in-person visit to obtain multimodal structural and functional MRI data, and biosamples.

525.00

Xuemei Huang
Mike Klemick - at mklemick@pennstatehealth.psu.edu or 717-531-0003, ext=283769
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00019729
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Inclusion Criteria:
Age ≥ 21 years at screening.
Previous participation in a Translational Brain Research Center (TBRC) study, including IRB protocols 40726, 11436, 37016, 5467, 37217 and 42368.
Confirmed living through Allegra if current status is unknown by research team.
Able and willing to sign the informed consent form or has a Legally Authorized Representative (LAR) who is able and willing to do so.
Able and willing to complete the minimum required study visit questionnaires that necessitate video PSH HIPAA-Compliant Zoom (i.e., MoCA, UPSIT, MDS-UPDRS) to the best of his ability, with or without the help of a caregiver.

Exclusion Criteria:
Unable to participate in consent procedures and does not have a LAR who is willing and able to do so.
Unable or unwilling to complete the minimum required study visit questionnaires that necessitate video PSH HIPAA-Compliant Zoom (i.e., MoCA, UPSIT, MDS-UPDRS).
Unwillingness to complete COVID-19 History Questionnaire.
Unwillingness to complete questionnaires and assessments remotely to the best of his ability.
For those willing to undergo an optional brain MRI, any condition that precludes its routine performance.
COVID-19, Neurology
Not applicable
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Brain Mechanisms of Overeating in Children

Reducing intake from large portions is of critical importance to preventing obesity. People consistently eat more when they are served larger portions, a phenomenon known as the portion size effect. The mechanisms of the portion size effect are not well understood, and investigating the underlying neurobiology that drives this phenomenon may inform the development of more effective obesity prevention programs. The proposed research will follow healthy weight children who vary by family risk for obesity to identify the neurobiological and appetitive traits that are implicated in overeating and weight gain during the critical pre-adolescent period. We expect results to confirm the hypothesis that reduced function of brain inhibitory pathways and increased activity in brain reward pathways in response to portion size cues contributes to excess intake with large portions and greater weight gain over time, particularly in children who have higher risk for obesity. The proposed studies will characterize the relationship between brain response to portion size and eating behavior and will allow us to determine whether brain and behavioral responses predict body fat gain during pre-adolescence. These studies will contribute essential information to our understanding of the pathways implicated in overeating and obesity and will facilitate the characterization of “at risk” phenotypes that can be targeted by prevention programs.

There will be seven in person visits with two DEXA measurements, one fMRI scan and five meals.

$350

Kathleen Keller
Kyle Hallisky - at kmh6587@psu.edu or 814-865-5169
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT03341247
STUDY00005357
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Inclusion Criteria:
The child must be age 7-8 when the first study visit is completed
The child must not have any food allergies to foods used in the study, learning disabilities, psychological diagnoses, red/green color blindness, or claustrophobia.
The child must not be taking any medications known to influence cognitive function, taste, appetite or blood flow
The child's BMI must be below the 90th percentile at the first visit
The biological mother and father must have a BMI between 18.5-25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 for mothers and greater than or equal to 25 kg/m2 for fathers (high-risk group) and 1 parent must attend all visits.

Exclusion Criteria:
Children will be excluded if they are not within the age requirements (< than 7 years old or > than 8 years-old at the first visit).
Children will be excluded if they have any food allergies, learning disabilities, psychological diagnoses, red/green color blindness, or claustrophobia
Children will be excluded if they are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow
Children will be excluded if their BMI is above the 90th percentile at the first visit
Families will be excluded if the biological mother or father do not fit the BMI requirements
Food & Nutrition, Prevention, Neurology
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State College, PA ,

Examining elderly traumatic brain injury and risk for neurodegeneration

The purpose of this proposal is to understand the risk factors for Alzheimer’s disease after TBI, including time since diagnosis, ethnicity, and genetic predictors. In Aim 1 the goal is to collect data in a large group of individuals with TBI to understand these interacting factors in predicting cognitive decline. Then in Aim 2, in a sub-group of individuals we use brain imaging methods in order to determine the network response associated with neurodegeneration decades post TBI. Ultimately, the ability to monitor the neural network response to injury-specific factors in combination with risk/resiliency factors (e.g., genetic, health) may bring greater precision to rehabilitation in TBI and aid in identifying patients at risk for neurodegeneration years prior to onset. Three specific aims were designed to clarify the role of neural recruitment in recovery from TBI: 



There will be one in person visit that lasts ~5 hours. It involves an MRI scan, blood pressure measurement, cognitive testing, and interviews about social and emotional wellbeing.

$150

Frank Hillary
Frank Hillary - at fgh3@psu.edu
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007561
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Inclusion Criteria:
>50 years of age
sustained a traumatic brain injury

Exclusion Criteria:
<50 years of age
history of neurological disorder such as stroke, epilepsy, or multiple sclerosis
history of bipolar
Neurology
Not applicable
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State College, PA ,