NCT01194661

Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury

Completed Last updated 19 November 2019

What this trial tests

trial in Traumatic Brain Injury in 129 participants. Completed in 16 November 2017.

Timeline

10 August 2010

16 November 2017

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	129
Start date	10 August 2010
Estimated completion	16 November 2017
Sites	1 location across United States

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Stroke — all drugs for Stroke →
• Headache — all drugs for Headache →
• PTSD — all drugs for PTSD →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 40, any sex, with Traumatic Brain Injury or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI.

Objectives:

* To determine the parts of the brain involved in suppressing an urge to act.
* To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement.

Eligibility:

\- Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers.

Design:

* This research study includes a screening visit and two study visits, each of which will last at least 2 hours.
* Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study.
* At the first study visit, participants will complete one of the following experiment tests in an MRI scanner.
* Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans.
* Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan.
* At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner.

Background:

\- Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI.

Objectives:

* To determine the parts of the brain involved in suppressing an urge to act.
* To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement.

Eligibility:

\- Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers.

Design:

* This research study includes a screening visit and two study visits, each of which will last at least 2 hours.
* Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study.
* At the first study visit, participants will complete one of the following experiment tests in an MRI scanner.
* Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans.
* Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan.
* At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.