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Protocol Details

Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-N-0185

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 40

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Inhibitory Control;
Executive Function;
fMRI;
TMS;
TBI

Recruitment Keyword(s)

Traumatic Brain Injury;
TBI;
Healthy Volunteer;
HV

Condition(s)

Traumatic Brain Injury;
Stroke;
Headache;
PTSD

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and StrokeDepartment of DefenseCenter for Neuroscience and Regenerative Medicine (CNRM)NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

1. Age 18 to 40

2. Able to give consent

3. Normal clinical examination for healthy subjects

4. Must be able to follow instructions and perform required tasks, and TBI patients must have the Mini-mental state examination (MMSE) score of 25 or above.

5. Clearly right dominant handedness as assessed by Handedness scales

MILD TBI:

Traumatically induced physiological disruption of brain function, as manifested by at least on the following:

1. Any loss of consciousness

2. Any loss of memory for events immediately before or after the accident (except for short-lasting benzodiazepines for sleep.

3. Focal neurological deficit(s) that may or may not be transient

4. Any alteration in metal state at the time of the accident (e.g. feeling dazed, disoriented or confused) and focal neurological deficit (s) that may or may not be transient, but where the severity of the injury does not exceed the following:

-Loss of consciousness (LOC) of approximately 30 min

-After 30 min, an initial Glasgow Coma Scale (GCS) sore of 13 - 15 (or clinically diagnosed concussion) and

-Post-traumatic amnesia (PTA) not greater than 24 hour

Moderate TBI:

Those meeting the same criteria as mild TBI plus any one of the following:

1. GCS of 9-12 (if available) or results of a clinical evaluation as moderate TBI

2. Mental status change or LOC 30 min to 24 hour

3. PTA 1-7 days

EXCLUSION CRITERIA:

1. Being diagnosed as an alcoholic or with drug addiction.

2. Chronic use of medications acting primarily on the central nervous system (e.g., carbamazepine, phenytoin, citalopram, and fluoxetine) except for short-lasting benzodiazepines for sleep

3. Pregnancy

4. Medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., dental braces, pacemakers, implanted medication pumps, cochlear devices, neural stimulators, certain metals in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia)

5. History of epilepsy (to avoid brain abnormalities other than mild to moderate TBI)

6. Less than three months post-TBI and with post traumatic stress disorder (PTSD) Check List (PCL) score of greater than or equal to 50

7. Penetrating head wound

8. For healthy volunteer, history of brain injury and/or structural MRI abnormality.


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Citations:

Anderson JR. Automaticity and the ACT* theory. Am J Psychol. 1992 Summer; 105(2):165-80.

Aron AR, Poldrack RA. Cortical and subcortical contributions to Stop signal response inhibition: role of the subthalamic nucleus. J Neurosci. 2006 Mar1;26(9):2424-33.

Aron AR, Behrens TE, Smith S, Frank MJ, Poldrack RA. Triangulating a cognitive control network using diffusion-weighted magnetic resonance imaging (MRI) and functional MRI. J Neurosci. 2007 Apr 4; 27(14):3743-52.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leonardo G. Cohen, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D54
10 CENTER DR
BETHESDA MD 20814
(301) 496-9782
cohenl1@mail.nih.gov

Rita Volochayev, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D51
10 CENTER DR
BETHESDA MD 20814
(301) 451-1335
volochar@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01194661

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