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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 |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Inhibitory Control; |
Recruitment Keyword(s) |
Traumatic Brain Injury; |
Condition(s) |
Traumatic Brain Injury; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- 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.
Eligibility
INCLUSION CRITERIA:
1. Age 18 to 40
2. Able to give consent
3. Normal neurological examination for healthy subjects
4. Must be able to follow instructions and perform required tasks, and have the Mini-mental state examination (MMSE) score of 25 or above.
5. Clearly dominant handedness (right or left) 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
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 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
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)
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 seizures (to avoid brain abnormalities other than mild to moderate TBI)
6. Less than three months post-TBI
7. Penetrating head wound
8. For healthy volunteer, history of brain injury and/or structural MRI abnormality.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Eric M. Wassermann, M.D. National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health 10 CENTER DR MSC 1440 BETHESDA MD 20892-1440 (301) 496-0151 wassermanne@ninds.nih.gov |
Rita Volochayev, C.R.N.P. National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health BG 10 RM 7D51 MSC 1428 10 CENTER DR BETHESDA MD 20892-1428 (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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