← Back to Search

Behavioural Intervention

Brain Stimulation & Imaging for Traumatic Brain Injury

Phase 1
Recruiting
Led By Leonardo G Cohen, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of having a sustained, traumatically induced (e.g., collision between the head and an object, or sudden acceleration/deceleration of the brain without direct
Age 18 to 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. typically, individuals complete the full study with 4-7 days.
Awards & highlights

Study Summary

This trial is looking at how different parts of the brain are involved in making decisions, and how those decisions may be hurt after TBI.

Who is the study for?
This trial is for adults aged 18 to 60 who have experienced a traumatic brain injury (TBI). Participants must be able to give consent, follow instructions, and perform tasks required by the study. They should not have significant neurological abnormalities unrelated to TBI.Check my eligibility
What is being tested?
The study investigates how TBI affects decision-making by using scans like PET, MRI, MEG and an intervention called transcranial direct current stimulation (tDCS), which stimulates the brain with a mild electrical current through sponges on the scalp.See study design
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode sites, itching or tingling sensations during stimulation, headache or fatigue after treatment. The imaging procedures are generally safe but can cause claustrophobia or discomfort from loud noises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a serious head injury from a sudden impact or movement.
Select...
I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. typically, individuals complete the full study with 4-7 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. typically, individuals complete the full study with 4-7 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers.
Secondary outcome measures
The secondary objectives of this protocol are to: determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and determine i...

Side effects data

From 2017 Phase 4 trial • 88 Patients • NCT02020408
2%
High blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
[11C]Raclopride, [11C]DASB, Amphetamine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment2 Interventions
up to 40 adult TBI patients between the ages of 18 and 60
Group II: 2Active Control1 Intervention
up to 40 adult healthy volunteers between the ages of 18 and 60
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~640

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,340 Previous Clinical Trials
649,281 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,533 Total Patients Enrolled
Leonardo G Cohen, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
12 Previous Clinical Trials
6,724 Total Patients Enrolled

Media Library

Traumatic Brain Injury Clinical Trial 2023: Decision-Making Task Highlights & Side Effects. Trial Name: NCT02169310 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include individuals older than twenty years of age?

"The upper and lower limits for age eligibility in this trial are 18 to 60 years old."

Answered by AI

Is there an opportunity for volunteers to participate in this research endeavor?

"Affirmative, the clinical trial is actively recruiting according to data on clinicaltrials.gov. This study was initially posted in November of 2014 and recently updated at the end of November 2022."

Answered by AI

Is it possible for me to enroll in this research project?

"This clinical trial is looking for approximately 80 individuals aged 18 to 60 with wounds. Those interested in participating should be sure they meet the requirements of this study."

Answered by AI

What is the scope of participants enrolled in this research endeavor?

"Affirmative. Details on clinicaltrials.gov demonstrate that this medical research, which was initially posted in November 2014, is actively seeking participants. Eighty individuals have to be recruited across 2 distinct hospitals."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Oregon
How old are they?
18 - 65
What site did they apply to?
National Institutes of Health Clinical Center, 9000 Rockville Pike
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. National Institutes of Health Clinical Center, 9000 Rockville Pike: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Neural Basis of Decision-Making Deficits in Traumatic Brain Injury
2014. "Neural Basis of Decision-Making Deficits in Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02169310.
All > Trauma > Traumatic Brain Injury
~12 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top