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56 Study Matches

Improving Autism Screening with Brain-Related miRNA

The central aim of this project is to characterize the expression of exosomal microRNA (miRNA) and nucleic acids in children with autism spectrum disorder (ASD). We propose to measure the expression of extracellular miRNA and nucleic acids in children with ASD. Expression levels of miRNA and nucleic acids from blood and saliva will be compared between children with autism and normally developing controls. The goal of this study will be to identify genetic regulatory mechanisms involved in ASD and provide potential biomarkers for diagnostic screening.
All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT02712853
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Inclusion Criteria:
Age: 1-4 years
Confirmed Diagnosis of Autism or Developmental Delay or Healthy Child
Exclusion Criteria:
Wards of the state
Sensory Impairment (blindness/deafness)
Confounding neurological condition (cerebral palsy, epilepsy)
Gastrostomy Tube Dependence
Active Peridontal Disease
Children's Health, Mental & Behavioral Health
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Hershey, 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.
Kara Hickok at kih5334@psu.edu or 814-865-5169
All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT03341247
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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

PA CURE Phase 1: Biomarkers of Traumatic Brain Injury (TBI)

The study seeks to identify the characteristics of brain function after traumatic brain injury (TBI). The data obtained through this study aims to help physicians better understand the characteristics of specific products released into the blood and cerebrospinal fluid (CSF) following a TBI, called biomarkers. In addition, we will store blood and CSF samples for later testing as new information becomes available. The long-term goal of this study is to provide physicians with the tools they need to diagnose brain injuries. This information may help doctors judge how severe a head injury is, if treatment needs to be adjusted, and it may help predict how well a patient recovers from the injury.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Traumatic brain injury within the preceding 48 hours
Current age 18-80 years
Head CT with acute intracranial pathology
Ability to undergo MR and PET imaging
Exclusion Criteria:
Penetrating TBI due to gunshot wound, shrapnel, or other metallic substance that would preclude patient from undergoing MR imaging
Pre-existing neurologic or neurodegenerative disorder or history of psychiatric conditions, such as major depressive disorder or psychosis
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with neuropsychological testing
Contra-indication to MR imaging, such as ferrous metal, pacemakers, body weight above 125 kg, or concerns about claustrophobia
Non-native English speakers (translations are not available/validated for most neuropsychological test measures).
Neurology
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Location
Hershey, PA

Brain potential reveals the effect of language immersion on L2 learning

In this project, we aim to understand how the environment influence language learning. Research in bilingualism and second language acquisition has demonstrated the high adaptability of the human brain in response to environmental input and behavioral experience. However, in the previous studies on second language (L2) learning, environmental factors that may lead to structural and functional changes in the brain have rarely been systematically investigated. The length of residence in an L2 environment (LoR), which strongly relates to the amount of language experience, is one environmental factor that can impact neural mechanisms underlying L2 processing. Thus, this project will examine the effect of LoR on the neural processing of English by native speakers of Mandarin.
Haoyun Zhang at hxz153@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
18-years of age or older

Right handed
Normal or corrected-to-normal vision
Either Native Monolingual English Speakers or Mandarin learners of English who do not know a third language
Exclusion Criteria:
A history of neurological disorders or language disorders
< 12 years of education
illiteracy
Language & Linguistics
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State College, PA

Multimodal brain MRI-guided understanding of non-motor outcomes in Parkinson's post DBS

This study will explore the relationship between multimodal brain MRI findings and cognitive/mood outcomes in Parkinson's Disease (PD) patients following Deep Brain Stimulation (DBS). Patients already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS to collect motor, neurobehavioral and physical therapy measurements.
Rachel Dokholyan at TBRC@pennstatehealth.psu.edu or 717-531-5233
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Age at least 18
Diagnosed with Parkinson's Disease
Undergoing DBS as part of standard of care
Able to provide informed consent
Exclusion Criteria:
Age less than 18
General contraindications to surgery
Pregnant or nursing women
Unable to undergo MRI for any reason
Atypical Parkinsonism
Neurology
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Location
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.
Savannah Olimpo at TBRC@pennstatehealth.psu.edu or 717-531-5233
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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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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Location
Hershey, 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: 


Frank Hillary at fgh3@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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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
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Study Locations

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Location
State College, PA

Pilot evaluation of a multisensory evoked potential brain-computer interface

A brain-computer interface (BCI) is a device that has the potential to restore communication by translating voluntarily controlled brain signals of intent. The P300 speller, a popular BCI paradigm, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to control a spelling interface. Those with advanced ALS experiencing the loss of voluntary muscular control may also experience cognitive changes that result in decreased capacity for BCI control using the P300 speller. With this pilot study, we aim to validate the performance of a combination of eye tracking and standard sensory testing to quantify intact sensory and cognitive processes necessary for the generation of a P300 response. Additionally, we will evaluate the association of these correlates with performance on a multisensor P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the viability of this system for future use in a patient group.
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
18 years of age or older
Fluent in written and spoken English.
Exclusion Criteria:
Those unable to undergo electroencephalography (EEG) due to either allergies to lotions, cuts on the scalp or active infections.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
Neurology
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Hershey, PA
State College, PA

KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA

Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03546582
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Inclusion Criteria:
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck
Exclusion Criteria:
Patients with distant metastases
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Cancer
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Hershey, PA

Site for MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) (S1827) (PSCI# 20-086)

The purpose of this study is to compare the effects of using brain MRIs alone versus brain MRIs plus PCI on the lifespan of patients with small cell lung cancer. The use of brain MRIs alone could reduce side effects of receiving PCI. This study is hoping to show that monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) is at least as good as the combination of PCI with MRI scans. There will be about 668 people taking part in this study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04155034
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Inclusion Criteria:
Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
Patient must have an MRI of the brain performed within 28 days prior to registration.
Patient must have Zubrod Performance Status of 0-2
Patient must be ≥ 18 years of age.
All adverse events from prior treatment must have resolved to ≤ Grade 2 (CTCAE Version 5.0) prior to randomization.
Exclusion Criteria:
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Patient must not have other metastatic malignancies requiring current active treatment.
Patient must not have any severe active comorbidities
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy.
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
Cancer
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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.
Diana Priestley at dkp5205@psu.edu or 814-865-0389
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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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

Site for Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck (PSCI# 20-106) (RTOG-1216)

To determine if the combination of atezolizumab, cisplatin, and IMRT is superior to standard cisplatin and IMRT in the HNSCC.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT01810913
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 Negative), larynx, or hypopharynx within 63 days prior to registration
Pathologic stage III or IV HNSCC, including no distant metastases
Zubrod Performance Status of 0-1 within 14 days prior to registration
Adequate hepatic function
Exclusion Criteria:
Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note that prior chemo for a different cancer is allowable
Severe, active co-morbidity
Grade 3-4 electrolyte abnormalities
Prior allergic reaction to cetuximab
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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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.
Chaleece Sandberg at cws18@psu.edu or 814-863-2006
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03550092
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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

Assessing cognitive and psychosocial mechanisms of Useful Field of View cognitive training using ecological momentary assessment

We are interested in how brain games impact everyday life in healthy older adults. Participants will play 20 hours of brain games on a study-provided laptop, and we will examine how the brain games impact everyday life. This study will be performed remotely in participants homes using study-provided laptops. Some participants may also participate in 2 optional visits with brain MRI scans at Penn State University and at home sleep monitoring.
Courtney Fine at cjf5860@psu.edu or 814-865-4773
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04651582
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Inclusion Criteria:
65 or older
no diagnosis of dementia
available for 6 months
Exclusion Criteria:
64 or younger
dementia or motor movement disorder diagnosis
cognitive training within past 2 years
Mental & Behavioral Health
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The Neural Basis of Pattern Learning in Human Adults

This research investigates how the human adult brain exploits patterns and regularities in the environment to learn.
Elisabeth Karuza at ekaruza@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Between 18-30 years old
Minimum High School education
Right-handed
Normal or corrected-to-normal vision/hearing
Fluent in English
Exclusion Criteria:
Individuals with a history of neurological injury or disease
Individuals taking medications that affect the brain or blood flow
Individuals greater than 300 lbs
Individuals who are claustrophobic
Individuals with contraindications to MRI scanning such as an implanted device
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State College, PA

Examining Cortical Lateralization of Motor Learning through Transcranial Stimulation

The aim of this study is to understand how brain stimulation affects learning of a novel task on a virtual reality system. Participation involves playing virtual reality games during non-invasive brain stimulation.
Brooke Dexheimer at brooke.dexheimer@psu.edu or 717-531-0003, ext=283146
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
right-handed
18-40 years old
Exclusion Criteria:
left handed or ambidextrous
neurological disease
movement disorder
major psychiatric diagnosis
orthopedic damage to the arms
Neurology, Mental & Behavioral Health
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Hershey, PA
State College, 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.
Berenice Anaya at bua25@psu.edu
All
All
This study is also accepting healthy volunteers
N/A
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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
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State College, PA

Site for Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
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Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function
Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
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Hershey, PA

Interlimb differences in Motor Control and Learning

This study examines how each brain hemisphere contributes to motor control and coordination. Participants play virtual reality/computer games to look at how their arms move during different activities.
Brooke Fosaaen at sainburglab@psu.edu or 814-865-7937
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
over the age of 18
Exclusion Criteria:
neurological disease
upper-extremity orthopedic injuries that interfere with participation
Neurology, Sports Medicine, Muscle & Bone
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Hershey, PA
State College, 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
N/A
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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
Neurology
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Hershey, PA

Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome

Postural tachycardia syndrome (POTS) is a chronic syndrome in which the heart beats too quickly when standing. POTS primarily affects young women. People with POTS also experience symptoms such as feeling faint, fatigue, nausea, and mental clouding or "brain fog." “Brain fog” is one of the most bothersome symptoms of POTS and it is unknown why people with POTS experience this symptom. Some studies have shown that POTS patients have problems with attention, memory and executive function (ability to plan, organize information, and adapt to changes) while seated and when upright. In this study, we will evaluate how brain function during mental tasks is affected in people with POTS compared to healthy volunteers. All volunteers will complete mental tasks while lying down and standing. If eligible, we will measure brain activity using functional magnetic resonance imaging (fMRI).The findings from this study will increase our understanding of the mental complaints in people with POTS, to hopefully help with development of new treatments.
Amanda Miller at aross1@pennstatehealth.psu.edu or 717-531-7676
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04137757
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Inclusion Criteria:
Men and women of all races
18- 60 years old
Previously Diagnosed with POTS or healthy people without chronic illness
Capable of giving informed consent
Exclusion Criteria:
Age <18 years or >60 years
Pregnant or breastfeeding women
Other potential causes for tachycardia (e.g. prolonged bed rest, dehydration)
Taking stimulant medications within the past 3 months as these may alter cognition
Unable to tolerate an MRI scanner (e.g. claustrophobia, implanted metal)
Heart & Vascular, Neurology
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Hershey, PA

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction

This is a Phase 3 study, which means that BIIB093 (study drug) has already been investigated in previous clinical research studies with a small number of people with large hemispheric infarction (LHI). These studies suggested that the study drug was safe, did not cause serious side effects or discomfort, and may reduce brain swelling, disability, and death in subjects with LHI. In this study, we want to investigate the study drug in a larger number of subjects (hundreds) to know more about it. LHI is a type of stroke. An ischemic stroke occurs when blood flow to parts of the brain is blocked, such as by a blood clot. This can cause damage to the brain. In LHI a large portion of the brain is damaged. People who have LHI can develop swelling of the brain called cerebral edema, which can worsen the symptoms and outcomes of LHI. Currently, there are no medications available to specifically reduce brain swelling caused by LHI. In this study, we want to investigate how well the study drug works to improve functional outcomes (the ability to do normal daily activities, such as walking and getting dressed) in subjects with LHI. This study will also look at the long-term effects of the study drug over time and see how safe the study drug is.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02864953
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Inclusion Criteria:
A clinical diagnosis of acute ischemic stroke in the MCA territory within 10 hours of symptom onset
Aged 18 to 85 years old, inclusive, at the time of informed consent
Screening NIHSS ≥10
Exclusion Criteria:
In the judgment of the Investigator, the subject is likely to have supportive care withdrawn in the first day
Commitment to decompressive craniectomy (DC) prior to enrollment
Evidence (clinical or imaging) of concurrent infarction in the contralateral hemisphere deemed by the Investigator to be sufficiently serious so as to affect functional outcome
Clinical signs of herniation and/or loss of other brain stem reflexes, attributable to edema or herniation according to the Investigator’s judgment
Brain hemorrhage (other than small petechial/punctate hemorrhages) on NCCT/MRI
Neurology
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Hershey, 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.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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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

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.
Brennen Harding at bharding@pennstatehealth.psu.edu or 717-531-5656
All
All
This study is also accepting healthy volunteers
NCT02901821
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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

A Phase II, Randomized, Open-Label Three-Arm Clinical Study To Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) that have Progressed after Platinum Therapy and Immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

This study is designed to compare pembrolizumab plus lenvatinib as a combination therapy and standard of care (SOC) chemotherapy and see if its safe and effective for patients with recurrent or metastatic head and neck squamous cell carcinoma.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04428151
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Inclusion Criteria:
Be male or female and at least 18 years of age on the day of signing informed consent.
Have histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC
Have experienced disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen with or without cetuximab.
Have submitted pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1,
Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate) not previously irradiated.
Exclusion Criteria:
Has carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease
Has any evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization
Has a history of (noninfectious) pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.
Cancer
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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.
All
Younger than 18 years old
This study is also accepting healthy volunteers
N/A
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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

Establishing the effect of flavor on the addictive potential of electronic cigarettes

For the current study, smokers will use an electronic cigarette in addition to their usual cigarettes for 4 weeks. The electronic cigarette will contain sweet or tobacco flavored liquid that may or may not contain nicotine. Participants will complete functional magnetic resonance imaging scans at the beginning and end of the study to measure how the brain responds to the electronic cigarette flavor.
Brianna Hoglen at abl@pennstatehealth.psu.edu or 717-531-5473
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT03905928
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Inclusion Criteria:
21-60 years old
Smoke at least 5 cigarettes per day
Smoke regular tobacco flavored cigarettes
Not currently interested in quitting smoking
Exclusion Criteria:
Unstable or significant medical conditions
Pregnant or nursing
Regular use of flavored tobacco products
Regular use of electronic cigarettes
Implanted metal in the body
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse
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Hershey, PA

Longitudinal Examination of Abstinence Maintenance and Relapse in Cigarette Smokers

This study is examining how the brain changes as people remain abstinent from smoking cigarettes over the course of approximately 1 year. We are using magnetic resonance imaging (MRI) to investigate how the brain's structure and function change over time in individuals who have recently quit smoking.
Eric Claus at edc5208@psu.edu or 814-865-2007
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Age 18-60 years
Right handed
Smoked cigarettes in the past
Recently quit smoking cigarettes
Exclusion Criteria:
History of neurological injury or disease
Contraindications for MRI (e.g., pacemaker, other implanted medical devices)
Claustrophobia
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse
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State College, PA

Functional magnetic resonance imaging (fMRI) and psychophysical studies of sensory perception and cognition

The purpose of this study is (1) to understand how the brain processes sensory information and (2) how this is affected by factors like blindness or synesthesia. In addition to behavioral testing, the study will use functional magnetic resonance imaging (fMRI) which enables us to take pictures of the brain while you are doing a task, using an instrument called an MRI scanner.
Simon Lacey at slacey2@pennstatehealth.psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Healthy adults over 18 years old
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia
Must pass MRI safety screen (if applicable)
Exclusion Criteria:
Pregnant women (excluded from fMRI studies)
Minors under the age of 18
Individuals who fail the MRI safety screen (may still do behavioral studies)
Neurology, Language & Linguistics, Vision & Eyes
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Hershey, PA

Remote testing for psychophysical studies of sensory perception and cognition

The purpose of this study is (1) to understand how the brain processes sensory information and (2) how this is affected by factors like blindness or synesthesia.
Michelle Douthitt at mdouthitt@pennstatehealth.psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Healthy adults over 18 years old
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia
Exclusion Criteria:
Minors under the age of 18
Neurology, Language & Linguistics, Vision & Eyes
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