Status:
COMPLETED
Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsors:
United States Department of Defense
Center for Neuroscience and Regenerative Medicine (CNRM)
Conditions:
Traumatic Brain Injury
Stroke
Eligibility:
All Genders
18-40 years
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 networ...
Detailed Description
Objectives Voluntarily stopping an on-going motor response has been shown to engage a specific prefrontal-basal-ganglia (PBG) neural network. However, it is not known whether the PBG network is also ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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:
- Those meeting the same criteria as mild TBI plus any one of the following:
- GCS of 9-12 (if available) or results of a clinical evaluation as moderate TBI
- Mental status change or LOC 30 min to 24 hour
- PTA 1-7 days
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
August 10 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01194661
Start Date
August 10 2010
End Date
November 16 2017
Last Update
November 19 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892