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Study matches: 43

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Validation of the PLS Functional Rating Scale (PLSFRS)

Multi-Site Test-Retest Reliability and Validity Study of PLS-Specific Clinimetric Scale, PLS Functional Rating Scale (PLSFRS)
Travis Haines at thaines@pennstatehealth.psu.edu or 717-531-0003, ext. 287666
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of primary lateral sclerosis (PLS)
Onset of symptoms within last 15 years
At least 20 years old
Exclusion Criteria:
Upper motor neuron symptoms and signs only in the legs
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N/A
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Hershey, PA

Memory and Aging Study

This research is being done to find out more about changes in the brain as we age and to determine if MRI, genetic (DNA) variations, and neuropsychological tests can be used to evaluate memory loss and cognitive impairment.
Lauren Spreen at lspreen@pennstatehealth.psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of Alzheimer's disease
Diagnosis of Mild Cognitive Impariment
Normal Controls-Cognitively normal functioning
Exclusion Criteria:
Neurological disease (e.g., stroke, tumor, Parkinson's disease, etc.)
Psychiatric disorder (e.g., bi-polar, schizophrenia, etc.)
History of chemotherapy
Presence of a cold or viral infection
Presence of a pacemaker, aneurysm clips, or any metal in body
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N/A
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Location
Hershey, PA

Crest-2: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

To assess if the proportion of patients with a primary event differs between patients treated with intensive medical management alone compared to CEA, or to CAS, in patients with high grade asymptomatic carotid stenosis. To assess whether intensive medical management differs from CEA and from CAS to maintain the level of cognitive function at 4 years of follow up To assess if there are treatment differences in major stroke, minor stroke, disabling stroke and tissue based stroke at 4 years, using an analytic approach identical to that for the primary aim. To assess if the CEA or CAS versus intensive medical management difference is affected by patient age, sex, severity of carotid stenosis, restenosis, risk factor level and during of the asymptomatic period
Deborah Hoffman at dhoffman1@pennstatehealth.psu.edu or 717 531 0003 x283063
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Age >/=35 years
Do you have documented stenosis of your carotid?
Have you had any neurologic symptoms on the same side as your stenosis
No medical history of stroke or TIA on the same side as the stenotic vessel in the previous 180 days
If female, not pregnant
Exclusion Criteria:
Prior stroke with residual disability
Symptomatic ICH within past 12 months
Chronic afib
Ejection fraction < 30%
Do you use an anticoagulant? What medication?
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NCT02089217
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Hershey, PA

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
Deprexis Team Roman at mhc147@psu.edu or 814-865-5578
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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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
Current psychotherapy for depression
Substantial neurocognitive impairments
Very severe depression
Started anti-depressants in the last 2 months
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Location
State College, PA

Tongue movement in adults with motor speech disorder

Tongue movement in adults with motor speech disorder
Elizabeth Rodriguez at ezr16@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
be a native speaker of American English
have normal hearing
between 18 and 40 years of age
have no known speech, language, learning or neurological disorders
have very little experience in communicating with people that have motor speech disorders
Exclusion Criteria:
younger than 18 years of age; older than 40 years of age
Not a speaker of American English only
With hearing impairment
have neurologic and/or speech/language disorders
have extensive experience in communicating with people that have motor speech disorders
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N/A
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Location
State College, PA

Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury

This research is being done to examine the relationship between body composition, metabolism, and dietary needs in people with Spinal Cord Injury.
Slavoski at PMR_research@pennstatehealth.psu.edu or 717-531-0003
All
18 year(s) or older
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
C4-T4 Spinal Cord Injury greater than 12 months
Motor Complete (AIS A & B) spinal cord injury
<5% change in body weight over the past 12 months
Exclusion Criteria:
<22% body fat
Coronary artery disease
Type 1 Diabetes or insulin requiring Type 2 Diabetes
Hypothyroidism
Renal Disease
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N/A
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Location
Hershey, PA

Nasality characteristics in adults with motor speech disorder

The goal of this proposed study is to understand nasality characteristics in individuals with dysarthria (motor speech disorder) secondary to ALS. The research question the proposed study seeks to answer is how does the perception of speakers’ hypernasality relate to the severity of their dysarthria and their nasalance scores.
Elizabeth Rodriguez at ezr16@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
are 18-40 years of age
are a speaker of American English only
have normal hearing
have no neurologic and/or speech/language disorders
have very little experience in communicating with people that have motor speech disorders
Exclusion Criteria:
younger than 18 years of age; older than 40 years of age
Not a speaker of American English only
With hearing impairment
have neurologic and/or speech/language disorders
have extensive experience in communicating with people that have motor speech disorders
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N/A
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Location
State College, PA

A Prospective Non-interventional Study in Subjects with Late-onset Pompe Disease who are Currently Being Treated with Enzyme Replacement Therapy

The study will collect information about disease-related traits in patients with Pompe disease who take enzyme replacement therapy to understand how ERT impacts their function.
Matthew Bankert at mbankert1@pennstatehealth.psu.edu or 717-531-0003, ext. 323351
All
Not specified
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Have a diagnosis of Pompe disease
Age 7-75
Must be receiving Lumizyme or Myozyme to treat your Pompe disease
Started Lumizyme or Myozyme at least 2 years ago
Be able to walk at least 200 meters in 6 minutes (with or without an assistive device)
Exclusion Criteria:
Use of ventilatory support for more than 6 hours while awake
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NCT03347253
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Hershey, PA

A Phase 2 Randomized, Placebo-Controlled Trial of Tocilizumab in Amyotrophic Lateral Sclerosis (ALS)

This is a multicenter, randomized, double-blind, placebo-controlled 16-week study evaluating the safety and tolerability of tocilizumab in subjects with sporadic ALS.
Travis Haines at thaines@pennstatehealth.psu.edu or 717-531-0003, ext. 287666
All
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Diagnosis of ALS
Age 18-75
Breathing capacity (vital capacity) of at least 40% predicted
Able to undergo lumbar puncture
Exclusion Criteria:
Prior use of tocilizumab/Actemra
Have a tracheostomy or diaphragm pacing system
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NCT02469896
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Hershey, PA

Complex interactions of behavior, genes, and environment in the multi-system characterization of the effects of sleep loss on health, cardio-metabolic disease risk, cognition, and the epigenome

The purpose of this study is to see what effects sleep restriction (sleeping less than needed each night for many nights in a row) has on metabolism, cardiovascular regulation, cognitive function, and epigenomic changes in various tissues. This is an 11-day inpatient study. All of the 11 days and nights of the study will be spent in your study room in the Clinical Research Center at Penn State where you will live for the entire 11 days and nights without going home. During different days of the study you will be participating in several study procedures. These include: • Having your sleep patterns recorded every night • Taking performance and memory tests at regular intervals on a tablet computer everyday • Taking tests during an fMRI on three different occasions • Having blood drawn while you stay sitting in bed for up to four hours at a stretch while we test how your body processes sugar, or food on six different occasions • Having a small sample of fat (adipose tissue) removed on 2 different occasions We will determine your eligibility to be in the study during a screening process that consists of 4 screening bisits. Each visit will take up to several hours to complete and the entire screening process will take about 3 weeks. Completion of all screening visits: $50 Daily rate while living in hospital during 11-day study: $150/day (total $1,650) Incentive bonus for completing entire 11-day laboratory study: $550 Payment upon full completion: $2,250
Nicole Nahmod at SleepingBrain@psu.edu or 814-867-5977
Male
18 year(s) or older
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Male ages 20-35
Non-smoker
Right-handed
Physically and mentally healthy
Willing to comply with screening and study procedures
Exclusion Criteria:
History of night work or recent travel across >2 time zone
Drug or alcohol dependency; History of certain medications and/or supplements
Certain food allergies or dietary restrictions
Acute, chronic, or debilitating medical condition or illness
History of psychiatric illness or disorder, including claustrophobia
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N/A
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Location
State College, PA

Echocardiographic Imaging of Cardiac Performances in Spinal Cord and Non-Spinal Cord Injury Adults (A Pilot Study)

This research is being done to assess if spinal cord injury patients’ impaired nervous system will lead to changes in heart function during changes in body position. Additionally, the study will compare the tetraplegic, paraplegic, and able-bodied individuals’ measurements of heart function variables during different body positions.
Kristin Slavoski at PMR_research@pennstatehealth.psu.edu or 7175310003 x283816
All
18 year(s) or older
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Motor Complete (AIS A & B) spinal cord injury
18-65 years old
Exclusion Criteria:
Autonomic dysreflexia
Pressure Injuries <1 year
Renal/Gall Bladder Stones
Recent fractures
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N/A
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Location
Hershey, 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 100 children with mTBI and 50 age- and gender-matched controls between the ages of five and twenty-one years. 2) Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.
Jennifer Stokes at jstokes@pennstatehealth.psu.edu
All
Not specified
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
5 to 21 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
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NCT02901821
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Hershey, 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).
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
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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
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NCT02586623
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Hershey, PA

A Retrospective Characterization of Response to Enzyme Replacement Therapy in Late-onset Pompe Disease

A Retrospective Characterization of Response to Enzyme Replacement Therapy in Late-onset Pompe Disease
Matthew Bankert at mbankert1@pennstatehealth.psu.edu or 717-531-0003, ext. 323351
All
Not specified
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Diagnosis of Pompe disease
Between ages 3-65, inclusive
Have received at least 2 years of enzyme replacement therapy (Lumizyme/Myozyme)
Exclusion Criteria:
Require the use of a wheelchair
Required invasive ventilator support when you started enzyme replacement therapy
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N/A
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Location
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 while in an MRI scanner. Parents can also complete the MRI scan if interested.
Ashley Carroll at acarroll@pennstatehealth.psu.edu or 717-531-0003
All
Younger than 18 years old
This study is also accepting healthy volunteers
Hide eligibility criteria
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.)
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N/A
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Location
Hershey, PA

Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)

This is a drug study that will examine whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS.
Jennifer Crossen at jcrossen@pennstatehealth.psu.edu or 717-531-0003, extension 280842
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite ALS as defined by revised El Escorial criteria.
Age 18 years or older.
Symptom onset of weakness or spasticity due to ALS ≤ 60 months prior to Screening Visit.
Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit.
Must be able to swallow capsules throughout the course of the study, according to Site Investigator judgment.
Exclusion Criteria:
Invasive ventilator dependence, such as tracheostomy.
Creatinine level greater than 1.5 mg/dL at screening.
SGOT (AST) / SGPT (ALT) greater than 3 times the upper limit of normal at screening.
History of known sensitivity or intolerability to mexiletine or lidocaine.
Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia.
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NCT02781454
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Hershey, PA

The influence of statins on reflex vasodilation

This study explores the effect of statin therapy (e.g. Lipitor) on the impaired function that occurs in the small blood vessels in the skin of humans who have high serum cholesterol. To do this, we examine the dilation of blood vessels that depends upon nitric oxide (a signaling substance made by the body) and the relation between the skin's nerves and skin blood flow. There are 3 groups of participants: o no statin, LDL &lt;149 o statin* for ≥ 3 months, LDL &lt;149 o no statin, LDL ≥149 * statin prescribed by personal physician to lower serum cholesterol This study uses the minimally invasive microdialysis and microneurography techniques as well as whole body heating.
Susan Slimak at sks31@psu.edu or 814-863-8556
All
18 year(s) or older
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
• men and women 50 – 75 years
• Blood pressure is <140 / <90 mmHg
• may or may not be taking a statin (e.g. Lipitor)
Exclusion Criteria:
• medications other than statin that could alter cardio and neurovascular function
• known cardiovascular or metabolic disease (hypertension, heart disease, diabetes); skin allergies, rash, or skin disease
• tobacco or recreational drug use
• allergy to latex
• pregnancy, breastfeeding, hormone replacement therapy
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N/A
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Location
State College, PA

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.
Marissa Reynolds at mlr5246@psu.edu or 8148655285
All
Younger than 18 years old
This study is also accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
No learning disabilities
Right handed
Age 7 or 8
No medications known to influence cognative function, taste, appetite or blood flow
The biological mother and biological father must have a body mass index either between 18.5
•25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 (high-risk group) and must be available to attend the visits with their child.
Exclusion Criteria:
Children would be excluded if they are not within the age requirements (< than 7 years old or > than 8 years-old at baseline).
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 they are left handed,
Children will be excluded if they report being claustrophobic
Families will be excluded if the biological mother/father has a body mass index < 18.5 kg/m2 or between 25-29.9 kg/m2.
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NCT03341247
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State College, PA

An Online Mindfulness Intervention for People with ALS and their Caregivers

This research is being done to find if an online mindfulness program can help people with ALS and their caregivers with quality of life.
Matt Bankert at mbankert1@pennstatehealth.psu.edu or 717-531-0003, ext. 323351
All
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Have a diagnosis of ALS
Have recent forced vital capacity (FVC) >50% predicted
Exclusion Criteria:
Participation in another mindfulness program or regular meditation within past 6 months
Taking antidepressants or anti-anxiety medication AND have NOT been on a stable dose for at least 30 days
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N/A
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Neurobiology of Inhibitory Motor Control in Adults with ADHD

The proposed research represents the first examination of motor, cognitive, and neural mechanisms of inhibitory control in adults with ADHD. This study will extend previous work that describes motor impairments in children with ADHD by providing a quantitative analysis of grip force control in adults with ADHD.
Marissa Reynolds at mlr5246@psu.edu or 814-867-5024
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Your are 18-25 years old and have symptoms of ADHD or ADD
You speak English as your native (first) language
You have, at minimum, a high school diploma or GED
You have no previous concussions that resulted in loss of consciousness for more than 10 minutes
If you take stimulant medication for your ADHD or ADD, you must be willing to not take the medication for 24 hours before your visit to our lab
Exclusion Criteria:
You are under age 18 or over age 25 or do not have symptoms of ADHD or ADD
English was not the first language you spoke
You have less than a high school education
You have had a concussion that resulted in loss of consciousness for more than 10 minutes
You, or someone in your immediate family, has been diagnosed with seizures, epilepsy, encephalitis, meningitis, musculoskeletal, neurological, autism spectrum, or psychological disorder involving psychosis
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N/A
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Location
Altoona, PA
DuBois, PA
State College, PA
Williamsport, PA

Imaging Dementia - Evidence for Amyloid Scanning (IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort Study

This research is being done to find out how brain imaging helps guide your doctors in how to treat your condition, and whether these changes in treatment lead to better medical outcomes. The research component is to study if the brain imaging will help your doctor treat you and benefit your health; the brain imaging itself is not part of the research, but a procedure recommended by your doctor as part of clinical care.
Swati Shah at sshah@pennstatehealth.psu.edu or 717-531-0003 x281203
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
65 and older
Medicare beneficiary with Medicare as primary insurance
Diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months
Head MRI and/or CT within 24 months prior to enrollment
Clinical laboratory assessment within 12 months prior to enrollment
Exclusion Criteria:
Normal cognition or subjective complaints that are not verified by cognitive testing
Amyloid status already known to patient
Current or previous enrollment in an anti-amyloid therapeutic trial
Cancer requiring active therapy (excluding non-melanoma skin cancer)
Residence in a skill nursing facility
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NCT02420756
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Location
Hershey, PA

P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI): Phase IIb Clinical Study

The purpose of this study is to determine a safe and effective dose of a new, investigational contrast agent, P03277 developed by Guerbet, a pharmaceutical company specialized in the discovery and manufacturing of contrast media for medical imaging. Investigational means that it has not been approved by the United States Food and Drug Administration (FDA). P03277 will be compared to another contrast agent, MultiHance® (Gadobenate Dimeglumine), which is approved by most health authorities including the FDA in the United States. This comparison will allow the sponsor to assess the effective dose (the dose that will allow the best contrast of images) and the safety of the study contrast agent (if this dose is well tolerated by subjects).
Swati Shah at sshah@pennstatehealth.psu.edu or 717-531-0003 x281203
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Presenting with known or highly suspected focal areas of disrupted Blood Brain Barrier, including at least 1 expected enhancing lesion of minimum 5 mm. This lesion must have been detected on a previous imaging procedure.
Subject scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the study.
Subject able and willing to participate to the study.
Subject having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any study related procedure being conducted.
Subject affiliated to national health insurance according to local regulatory requirements.
Exclusion Criteria:
Subject presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated eGFR <60 mL/min/1.73 m² based on one eGFR assessment performed the day of the MRI prior to the first contrast agent injection.
Subject presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
Pregnant or breast-feeding female
Subject having received any investigational medicinal product within 30 days prior to study entry.
Subject having received any contrast agent (MRI or CT) within 3 days prior to study products administration, or scheduled to receive any contrast agent during the course of the study or within 24 hours after the second study product administration.
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NCT02633501
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Location
Hershey, PA

Central Mechanisms of Neurovascular Dysfunction in Human Depression

Our goal is to identify what leads to the increased risk of cardiovascular disease and stroke in adults with depression. This study may help identify treatments or preventative strategies that will work best to reduce the risk of cardiovascular disease, stroke, and death in these patients. Subjects will be between 18 and 40 years. Three subject groups will be recruited: 1. Healthy control (HC) subjects will not have a family history of Major Depressive Disorder (MDD) or major psychiatric illness 2. MDD patients will have clinically significant depression (non-medicated) 3. Selective serotonin reuptake inhibitor (SSRI)-treated adults (MDD in remission; monotherapy) will have been treated for at least 8 weeks prior to study enrollment A medical screening determines study eligibility. The screening includes a physical exam and medical history, height, weight, and waist circumference measurements, and recording the electrical activity of the heart (ECG). Screening also includes a blood draw for basic blood biochemistry, including a lipid profile and assessment of liver and kidney function. Subject-groups are matched for age and sex. During the experiments, we assess nervous system activity and blood pressure continuously. The experiments include intravenous infusion of substances that alter dilation or constriction of blood vessels. These substances work by promoting or blocking certain steps in the signaling pathways that control blood flow. This technique allows us to compare differences between subject-groups in the mechanisms governing the nervous system input in the control of blood flow. This project includes blood draws and the recording of nerve activity in the leg.
Susan Slimak at sks31@psu.edu or 814-863-8556
All
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Men and women 18 – 40 years
Blood pressure <140 / <90 mmHg; body mass index <30 kg∙m-2
Healthy control (HC) subjects: no family history of Major Depressive Disorder (MDD) or major psychiatric illness
MDD patients: have clinically significant depression (non-medicated)
SSRI-treated adults (MDD in remission; monotherapy): treated for at least 8 weeks prior to study enrollment
Exclusion Criteria:
psychiatric illness aside from MDD (including bipolar disorder, panic disorder, schizophrenia)
psychiatric treatment with drugs other than SSRIs
cardiovascular, renal, or metabolic disease (hypertension, heart disease, diabetes, hyperlipidemia)
medications that could alter neurovascular function
Pregnant or post menopausal
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N/A
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Location
State College, PA

Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

This study will evaluate and compare the health benefits of using functional electrical stimulation for lower extremity exercise with diet versus diet alone in adults with spinal cord injury.
Kristin Slavoski, MS at PMR_research@pennstatehealth.psu.edu or 717-531-0003 x283816
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
C4-T4 Spinal Cord Injury greater than 12 months
Motor Complete (AIS A & B) spinal cord injury
<5% change in body weight over the past 12 months
Exclusion Criteria:
Participation in an FES or ACE exercise program within the past 3 months
Uncontrolled autonomic dysreflexia
Deep vein thrombosis
<22% body fat
Diabetes or coronary artery disease
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N/A
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Hershey, PA

Motor Synergies in Neurological Disorders

The main purpose of this study is to examine changes in motor synergies that accompany common neurological disorders such as Parkinson's disease, stroke, olivo-ponto-cerebellar atrophy, essential tremor, amyotrophic lateral sclerosis, multiple sclerosis, and spinal cord injury. Patients and control subjects will be asked to perform simple motor tasks such as pressing, manipulating a hand-held object, reaching, standing quietly, swaying, and initiating a step. Analysis of multi-digit, multi-joint, and multi-muscle synergies will be performed using the framework of the uncontrolled manifold hypothesis. The study will have two main objectives. First, to better understand the neurophysiological mechanisms involved in motor coordination. Second, to identify and quantify disorders of motor coordination specific for particular disease states and their changes with disease progression and treatment.
Tyler Corson at tcorson@pennstatehealth.psu.edu or 717-531-0003
All
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
No sensory deficit
No major cognative deficit
No history of arthritis, carpal tunnel syndrome, or any other disease which would hinder peripheral movement
No history of drug or alcohol abuse
Exclusion Criteria:
Unable to complete study test
Evidence of severe memory or cognitive decline
History or arthritis, carpal tunnel or any other peripheral disease which would hinder movement
History of alcohol or drug abuse
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N/A
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Hershey, PA
State College, PA

A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis

A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
Jennifer Crossen at jcrossen@pennstatehealth.psu.edu or 717-531-0003, ext. 280842
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Have ALS
Starting experiencing ALS symptoms within the past 2 years
Have breathing capacities of 60% or greater
Willing to receive injections
Exclusion Criteria:
Use BiPAP or CPAP at night
Have a tracheostomy or diaphragm pacing system
Have a history of sensitivity to porcine (pig) protein products
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NCT03068754
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Hershey, PA

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease
Ruth Stewart at rstewart@pennstatehealth.psu.edu or 717-531-0003
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of Charcot Marie Tooth disease
Experience at least 5 muscle cramps per week
Exclusion Criteria:
Major gastrointestinal disorders or oral or esophageal lesions/ulcers
Significant swallowing problems
Inability to tolerate a spicy sensation in the mouth or stomach
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NCT03254199
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Hershey, PA

A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and safety of repeated biweekly infusions of neoGAA (GZ402666) and alglucosidase alfa in treatment-naïve patients with late-onset Pompe disease

A phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and safety of repeated biweekly infusions of neoGAA (GZ402666) and alglucosidase alfa in treatment-naïve patients with late-onset Pompe disease
Ruth Stewart at rstewart@pennstatehealth.psu.edu or 717-531-0003
All
Not specified
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of Pompe disease
Exclusion Criteria:
Under 3 years old
Wheelchair dependent
Has had treatment with alglucosidase alfa (Lumizyme) or any investigational therapy for Pompe disease
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NCT02782741
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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.
Jianli Wang at jwang2@pennstatehealth.psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
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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
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N/A
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Hershey, PA

Fabry Registry

The Registry is a multi-center, international, longitudinal, observational program for patients with Fabry disease that was designed to track the natural history and outcomes of patients. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research-related purposes. The long-term program will proceed for a minimum of 15 years.
Anne Morris at amorris2@pennstatehealth.psu.edu or 717-531-0003, ext. 289123
All
Not specified
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Have Fabry Disease
Be willing an able to provide written informed consent
Exclusion Criteria:
None
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NCT00196742
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