Clinical Trial Testing if an FDA Approved Medication Changes Stress Responses

Official Title
Orexin Receptor Antagonists as Modulators of Threat Sensitivity in individuals with Alcohol Use Disorder
Purpose

The purpose of this study is to see if BELSOMRA, an FDA approved medication that is prescribed to treat insomnia, changes the body’s response to stress. Participation in the study includes 3 or 5 in-person lab visits (depending on randomization), which include EEG and MRI. Nearly all visits are 1.5 hours long, with the exception of one that is 4-5 hours in duration. Visits are flexible and scheduled at your convenience. Participants take the medication (or placebo) for 4 weeks, during which participation is only composed of virtual surveys via a smartphone app.

The total length of participation in the study is 1.5-2 months depending on scheduling/availability.

Could this study be right for you?

Eligibility Criteria:

  • 18-65 years old
  • Generally medically and physically healthy
  • Regular alcohol use

Exclusion Criteria:

  • Diagnosis of bipolar disorder, schizophrenia, mania, or psychosis
  • Currently pregnant or trying to become pregnant (female)
  • Presence of ferrous-containing metal in the body
  • Inability to tolerate enclosed spaces
     

Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range
18 - 65

A Study About the Development of Learning in African-American/Black Children

Official Title
Ontogenesis of Categorization; Linking development, mechanisms, and biology
Purpose

The purpose of this study is to investigate the early development of attention, learning, and memory during childhood. Participation in this study includes 4, 90-minute-long visits to the lab per year. During these visits, your child will play 2-3 fun, computerized games. These games are designed to assess various aspects of their cognitive ability. 

The duration of the study will last 4 years.

Could this study be right for you?

Eligibility Criteria: 

  • African-American/Black children who are 4 years old 
Age Range
4 - 4

A Study About Gene Therapy for Early Alzheimer’s Disease (AD) and Mild Cognitive Impairment (MCI)

Official Title
A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of AAV2-BDNF [Adeno-Associated Virus (AAV)-based, Vector-Mediated Delivery of Human Brain Derived Neurotrophic Factor] in Subjects with Early Alzheimer’s Disease and Mild Cognitive Impairment
Purpose

The primary aim of this study is to determine whether administration of the nervous system growth factor "Brain-Deruved Neurotrophic Factor" (BDNF) to eligible patients with Alzheimer's disease and Mild Cognitive Impairment is safe and tolerable. This study will be used to determine whether BDNF administration reduces neuronal loss and rebuilds synapses in the brain of patients with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI). 

Could this study be right for you?
  • Male and Females aged 50 years or older
  • Diagnosis of dementia due to Alzheimer's Disease/Diagnosis of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease
  • A caregiver is available who has frequent contact with the subject, agrees to observe for adverse events, and will accompany the subject to all clinic visits for the duration of the protocol
  • CT or MRI scans within 24 months prior to screening without evidence of an infection, infarction, or other focal 

Inclusion Criteria varies, please contact Study Coordinator for more information.

The below Exclusion Criteria apply to both the AD and MCI groups.

  • Any significant neurological disease other than suspected incipient disease
  • History of schizophrenia 
  • History of systemic cancer within the past 18 months (non-metastatic skin cancers are acceptable).
  • Any significant systemic illness or unstable medical conditions which could lead to difficulty complying with the protocol
  • Use of any investigational drugs within thirty days or five half-lives, whichever is longer, prior to screening.

Exclusion Criteria varies, please contact Study Coordinator for more information. 

Age Range
50 and up

An Observational Study to Examine School Transition after Traumatic Brain Injury

Official Title
STATBI: School Transitions after Traumatic Brain Injury
Purpose

The purpose of this study is to understand the best ways to help students return to school after brain injury of any severity. This is important to study because finding the best ways to help students go back to school right after brain injury, and over time, can help improve student success and recovery.

Your participation in the study would take place when you/your child begins the study and then at 3 months, 6 months, 12 months, 2 years (if applicable) and 3 years (if applicable) after the study starts.

Could this study be right for you?

• Students aged 5 to 18 years old
• In kindergarten through 12th grade
• Must Speak English
• Traumatic Brain Injury (TBI) of any severity
• Parent/caregiver is willing to share medical and academic information with the research team (all study activities are virtual/remote)

Age Range
5 and up

A Study about Fitness, Aging, and Stress in People with Traumatic Brain Injury

Official Title
Fitness, Aging, Stress & TBI Exposure Repository (FASTER)
Purpose

The purpose this study is to examine how individual differences in health changes (muscle strength, blood pressure) and behavioral changes (sleep, physical activity) impact memory, attention, and the brain. We study these relationships in among a variety of older adults, including those with a history of concussion, traumatic brain injury (TBI), and posttraumatic stress disorder (PTSD). The long-term goal of this project is to identify modifiable factors that exacerbate or protect from age-related cognitive decline.

Could this study be right for you?

Eligibility Criteria: • Aged 18 years and older • Speak English • History of concussion, traumatic brain injury, and/or posttraumatic stress disorder • Must have primary care physician

Age Range
18 and up

Perinatal Arterial Stroke: The I-ACQUIRE Study

Official Title
Perinatal Arterial Stroke: The I-ACQUIRE Study
Purpose

Children who suffered a stroke before or shortly after being born that was caused by blockage of blood flow in an artery, it often results in the child showing some weakness on one side of their body.

With this study, we want to find out if a type of therapy may help children who have weakness on one side of their body due to perinatal arterial ischemic stroke, learn how to better use their weaker arm.

All children will be in the study for about 13 - 15 months. Some children may be in the study for a longer period, depending on which treatment they receive during Phase 1 of the study. The I-ACQUIRE therapy involves fun learning and play, self-help activities, and manipulating interesting toys and objects.

Could this study be right for you?

- Your child must be between the ages of 8 and 36 months old when beginning this study
- Your child must have suffered an a perinatal arterial ischemic stroke
- Upper limb weakness
- Parents must be able to participate at least 1x/week for therapy and 40-60 minutes/day at home

A study on language impairment following a stroke

Official Title
Laying the Groundwork for Personalized Medicine in Aphasia Therapy: Genetic and Cognitive Predictors of Restorative Treatment Response
Purpose

This NIH-funded project will investigate patient-specific factors that may influence response to therapy for language impairment after stroke, or aphasia. Results from this work will assist with better estimation of prognosis for stroke survivors with aphasia, which could empower patients and families to make more informed health care decisions about how to pursue the most appropriate rehabilitation services based on their unique characteristics, such as genetics, cognitive skills, and brain structure after stroke.

Could this study be right for you?

Participants must meet the following criteria:
- Native English speaker
- Able to have an MRI
- Had only one stroke (in the left hemisphere of the brain)

Age Range
18 and up

MeSo Study

Official Title
Mechanisms of Self and Other Evaluation (MeSO Study)
Purpose

The purpose of this study is to better understand the way the brain works in people who have depression and people who have previously been depressed. We are also testing healthy subjects for comparison. We hope our findings will lead to better ways to diagnose and treat mood disorders in the future. Participation involves an initial phone call and a 2 to 4 hour visit to find out if you are eligible. This visit will include completing questionnaires and interviews. If eligible, participants will have a second 3-5 hour visit for an MRI scan. Two months after the scan, participants will complete daily online questionnaires for 7 days. This process is repeated 2 months later (4 months after the scan). 

Could this study be right for you?

You may be eligible for this study if you: • Are between the ages of 18-40 • Are right-handed • Do not have a history of neurological disorders (e.g., seizures, head injury, etc.) • Do not have major medical problems (e.g., stroke, heart disease, high blood pressure, endocrine disorders, etc.) • Have normal vision, vision that is corrected to normal with glasses or contacts • Are willing and able to undergo fMRI scanning (not claustrophobic, no non-removable metal in your body) • Are not pregnant

Age Range
18 and up

Cognition and Brain Circuitry

Official Title
Cognition and Brain Circuitry
Purpose

The purpose of the study is to look at how our brain networks interact for different mental functions and how individual differences in brain structure and function determines individual differences in behavior. During this study, we use magnetic resonance imaging methods: functional magnetic resonance imaging (fMRI) and diffusion weighted imaging (DWI). Functional MRI (fMRI) and DWI are typical imaging methods that use a strong magnetic field and radio waves to make pictures of your body. The total length of the study will be between 3 and 4 hours, including up to 2 hours outside the MRI scanner and 2 hours in the scanner.

Could this study be right for you?

- Healthy adults between 18-40 years of age - Have normal or corrected-to-normal vision

Age Range
18 and up

Learning and Improving Alzheimer's Patient-Caregiver Relationships

Official Title
Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships via Smart Healthcare Technology
Purpose

The purpose of this study is to explore how family caregivers and persons with memory loss communicate and if certain ways of handling stress, such as mindfulness-based self managements, are helpful for family caregivers. You will be in the study for up to four months from the time of consent to the time of final study data collection. There will be 4 telephone or video calls, and each will take approximately 30 – 135 minutes.

Could this study be right for you?

Caregivers who will participate in this study need to: 1) be aged 21 years or older 2) be an informal, unpaid caregiver who lives with the care recipient 3) be fluent in English 4) have functioning home Wifi The inclusion criteria for care recipients (persons with memory loss) are: 1) females and males age 60-99 years 2) history of memory loss 3) community-dwelling (living in the home) 4) fluent in English

Age Range
21 and up