Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury

NCT01194661 | Completed

• 2 other identifiers: 10018510-N-0185
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Stroke; Headache; PTSD

Keywords

Inhibitory Control; Executive Function; fMRI; TMS; TBI; Traumatic Brain Injury; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (2)

• Task-dependent and independent fMRI BOLD signal

  Ongoing

• TMS effects on behavioral performance

  Ongoing

Secondary Outcomes (2)

• Behavioral performance data (reaction time and accuracy)

  Ongoing

• White matter fiber integrity in TBI patients estimated by the degree of fractional anisotropy (FA) from diffusion tensor imaging (DTI) signals.

  Ongoing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 40
• Able to give consent
• Normal clinical examination for healthy subjects
• 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.
• 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:
• Any loss of consciousness
• Any loss of memory for events immediately before or after the accident (except for short-lasting benzodiazepines for sleep.
• Focal neurological deficit(s) that may or may not be transient
• 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:

You may not qualify if:

• Being diagnosed as an alcoholic or with drug addiction.
• Chronic use of medications acting primarily on the central nervous system such as those for seizures (e.g., carbamazepine, phenytoin) except for short-lasting benzodiazepines for sleep and antidepressants (e.g., SSRIs and SNRIs).
• Pregnancy
• 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)
• History of epilepsy (to avoid brain abnormalities other than mild to moderate TBI)
• Less than three months post-TBI and with severe post traumatic stress disorder (PTSD) or PTSD Check List (PCL) score \> 60
• Penetrating head wound
• For healthy volunteer, history of brain injury and/or structural MRI abnormality.
• Staff from our section

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• United States Department of Defense: collaborator
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• National Institutes of Health Clinical Center (CC): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

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

  PMID: 1621879 BACKGROUND

• Aron AR, Poldrack RA. Cortical and subcortical contributions to Stop signal response inhibition: role of the subthalamic nucleus. J Neurosci. 2006 Mar 1;26(9):2424-33. doi: 10.1523/JNEUROSCI.4682-05.2006.

  PMID: 16510720 BACKGROUND

• 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. doi: 10.1523/JNEUROSCI.0519-07.2007.

  PMID: 17409238 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Headache; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Leonardo G Cohen, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: August 10, 2010
• Study Completion: November 16, 2017
• Last Updated: November 19, 2019

Record last verified: 2017-11-16

Locations

US (1)