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

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

Vercise™ DBS Registry

Official Title
Registry of Deep Brain Stimulation with the VERCISE™ System: Vercise™ DBS Registry
Purpose

The purpose of this study is to record the personal experiences of those who have had Deep Brain Stimulation (DBS) using the Vercise™ System, for the treatment of Parkinson's Disease.

Could this study be right for you?

You may be eligible if you are:
- At least 18 years of age
- Planning to receive the currently available Vercise™ System and/or any new commercially approved parts such as leads, extension, Adaptor, CP, etc. that is works with the Vercise System

Age Range
18 and up

Abbott DBS (Deep Brain Stimulation) Registry

Official Title
ABT-CIP-10300: Abbott DBS Registry of Outcomes for Indications over Time (ADROIT)
Purpose

The purpose of this study is to collect information and evaluate outcomes for Abbott Deep Brain Stimulation (DBS) systems that are approved and sold in your country.

In order to evaluate how the DBS system performs, data will be collected before, during and after DBS implant when you visit the study doctor. The data collected will include information on your movements, feelings, daily activities, and DBS program settings.

The information gathered in this study will add to the understanding of treatment options for future patients receiving DBS.

Could this study be right for you?

Inclusion Criteria:

- You are scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 3 months

Exclusion Criteria:

- You are currently enrolled or plan to enroll in another study that may alter the results of this clinical investigation
- You have another disease, conditions, or other medical, social, or psychological conditions that could limit the your ability to participate in the clinical investigation or to satisfy follow-up requirements

A Study to Evaluate an Investigational Drug (NLY01)Treatment to be used in Early-Stage Parkinson’s Disease

Official Title
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson’s Disease
Purpose

This research is studying a new drug, NLY01, in a large number of persons to learn about its effects in people with early-stage Parkinson’s disease (PD). Researchers want to know whether NLY01 helps lessen symptoms and signs of early PD, as well as slow the progression of the disease.

You will have a 2 in 3 chance of receiving NLY01 and a 1 in 3 chance of receiving a placebo, sterile salt water that looks like NLY01 but does not contain the study drug.

The total amount of time for you to be in the study will be approximately 45 to 54 weeks.

Could this study be right for you?

Inclusion:
- Man or woman, at least 30 to 80 years old
- Have early-stage Parkinson's disease
- Not be on any current treatments for PD
- If of reproductive potential, willing and able to use a highly effective form of birth control during the study and for 30 days following last dose of study material

* Other criteria for eligibility apply

Exclusion:
- Diagnosis of secondary or atypical parkinsonism
- Onset of any parkinsonian motor sign or symptom >5 years before Screening Visit
- Previous surgical procedure for PD
- Clinically significant medical, surgical, psychiatric, or laboratory abnormality
- Has an ECG or clinical evidence of potentially unstable heart disease
- Medical or recreational use of marijuana or THC-containing compounds within 3 months of the Screening Visit

* Other criteria for exclusion apply

Age Range
30 and up

A Study to Evaluate an Investigational Drug (tavapadon) as a Possible Treatment in Early Parkinson’s Disease

Official Title
A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, 27-WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)
Purpose

The main purpose of this study is to learn how well tavapadon (the study drug) works as a possible treatment for Parkinson’s disease and how safe the study drug is. The target dose range of tavapadon being studied is 5 to 15 mg once daily.

If you choose to participate in this study, you may receive the study drug, or you may receive placebo. A placebo is an inactive material, such as a sugar pill, that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
You will be in this study for approximately 35 weeks, which includes a screening visit and safety follow up, and you will need to come to the study center at least 11 times over this period.

Could this study be right for you?

You may be eligible if you:
• Are Between the ages of 40 to 80 years
• Are willing to practice effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial if you are a sexually active man or woman of childbearing potential
• Were diagnosed more than 3 years ago
• Willing and able to not use any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.

You will be excluded if you:
• Have a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post-stroke parkinsonism).
• Have had previous surgical intervention (eg, deep brain stimulation) for PD or for whom such a procedure is planned or anticipated during the trial period.
• Have hypertension.
• Have previously participated in any tavapadon trial, including this trial, and received IMP.
• Have received treatment with any other investigational drug within 60 days before signing the ICF.

Age Range
40 and up

A Study to Compare Medications in Patients with Advanced Parkinson's Disease

Official Title
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
Purpose

The purpose of this study is to find out how well ABBV-951 works to control Parkinson's disease symptoms compared to oral Carbidopa (CD)/Levodopa (LD). The study is also seeking to test whether ABBV-951 is well tolerated in patients with Parkinson's disease.

Could this study be right for you?

1. Male or female, age 30 or older
2. Has not received deep brain stimulation, Carbidopa (CD)/Levodopa (LD) enteral suspension, or any other Parkinson's Disease (PD) medication as continuous daily infusion
3. Subject does not have a history of significant skin conditions or disorders
4. Subject does not have a recent (within 6 months before screening) history of drug or alcohol abuse
5) Subject does not have a history or presence of psychotic episodes
6) Subject does not have other clinically significant unstable medical conditions
7) Subject must have a diagnosis of levodopa-responsive idiopathic PD

* other eligibility criteria to be discussed/reviewed with the study team

Age Range
30 and up

Decision-Making Abilities and Testamentary Capacity Among Older Adults

Official Title
Decision-Making Abilities and Testamentary Capacity Among Older Adults
Purpose

The overall goal of this research is to examine factors such as social resources, personality characteristics, and neurocognitive functioning in relation to decision-making abilities testamentary capacity among healthy older adults.

Another purpose of this research study is to evaluate the impact of Problem-Solving Treatment-Primary Care (PST-PC), a cognitive-behavioral therapeutic approach, on decision making among healthy older adults. PST-PC involves a seven-step model, in which participants identify problems to be solved, discuss and evaluate different resolutions to reach desired goals; create action plans to accomplish determined goals; and evaluate their effectiveness in resolving designated problems.

We will compare the effectiveness of PST-PC on individuals who will not receive any intervention.

A no treatment control group of older adult participants will also be recruited to compare the effectiveness of PST-PC to individuals who do not receive the intervention. This no treatment control group will composed of participants who do not receive the PST-PC sessions.

Could this study be right for you?

Inclusion Criteria:
-adults aged 65 and older
- Must be independently-living and community-dwelling
- Participants must be willing to undergo a health interview to rule out outstanding medical and psychiatric conditions
- Adequate sensory abilities

Exclusion Criteria:

- A history of psychiatric illness necessitating inpatient treatment
- Participants with self-reported depression and/or anxiety exceeding mild levels of clinical severity

Age Range
65 and up

A Study Utilizing Functional Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery

Official Title
Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery
Purpose

The goal of this study is to understand if there are any changes to the connections between the cells in the brain before and after the ultrasound surgery for the treatment of Essential Tremor. This will be done by comparing patients who have had ultrasound surgery and Essential Tremor with healthy individuals. This study may help us to better target the tremor region in the brain during the ultrasound surgery.

Could this study be right for you?

- You must be between the ages of 40 and 85
- Willing to have MRI imaging of the brain

Age Range
40 and up