Status:
TERMINATED
Moving a Paralyzed Hand Through Use of a Brain-Computer Interface
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsors:
Center for Neuroscience and Regenerative Medicine (CNRM)
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Brief Summary
This study will gain information on methods of control of a prosthetic arm in stroke patients or traumatic brain inury patients through a technique called "brain-computer interface" (BCI). BCI allows ...
Detailed Description
Objective: Individuals who have suffered a stroke or traumatic brain injury (TBI) may benefit from the development of new rehabilitative interventions that can improve motor recovery after injury. The...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - PATIENTS COMMON CRITERIA:
- Between the ages of 18 and 80 years. Substantial unilateral motor impairment, defined by MRC scores less than or equal to 2.
- INCLUSION CRITERIA - CHRONIC STROKE PATIENTS:
- At least 12 months post thromboembolic non-hemorrhagic hemispheric or hemorrhagic hemispheric subcortical lesions.
- INCLUSION CRITERIA - TBI PATIENTS:
- At least 12 months post mild to moderate traumatic brain injury.
- INCLUSION CRITERIA - HEALTHY VOLUNTEERS:
- Between the ages of 18 and 80 years
- EXCLUSION CRITERIA:
- We will exclude any stroke patient, TBI patient, or healthy volunteer if one of the following applies:
- History of alcohol or drug abuse.
- History of epilepsy (TMS and tDCS components only).
- Pregnancy
- MRI contraindications.
- Cardiac pacemakers.
- Intracardiac lines.
- Implanted medication pumps.
- Neural stimulators.
- Eye, blood vessel, cochlear, or eye implants.
- Increased intracranial pressure as evaluated.
- Metal in the cranium except in the mouth.
- Dental braces.
- Metal fragments from occupational exposure.
- Surgical clips in or near the brain.
- Inability to perform study tasks.
- Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less) that would prevent their ability to give informed consent and/or perform the study tasks.
- Uncontrolled medical (e.g. cardiovascular disease expressed as uncontrolled arrhythmias, shortness of breath, or overt signs of severe peripheral edema at the initial neurological exam, severe rheumatoid arthritis, arthritic joint deformity, active cancer or renal disease), or psychiatric problems as defined in the DSM IV.
- EXCLUSION CRITERIA - TBI PATIENTS:
- Post-traumatic seizures (TMS component only).
- Instability of psychoactive medication in the past 2 months.
- Pending litigation regarding the trauma.
- Absent changes in both Glascow Coma Scale and mental status following injury.
- Outpatients who are unable to make a 12-week commitment.
- Inpatients who are unable to make a 15 day commitment.
- Comprehensive aphasia.
- EXCLUSION CRITERIA - CHRONIC STROKE PATIENTS:
- Cerebellar lesions.
- More than one stroke in the middle cerebral artery territory.
- Bilateral motor impairment.
- Initiation of an exercise or rehabilitation program that could affect experimental results.
- Outpatients who are unable to make a 12-week commitment.
- Inpatients who are unable to make a 15 day commitment.
- Comprehensive aphasia.
- EXCLUSION CRITERIA - HEALTHY VOLUNTEERS:
- Inability to make a 12-week commitment.
Exclusion
Key Trial Info
Start Date :
October 17 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 23 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00242242
Start Date
October 17 2005
End Date
July 23 2013
Last Update
November 25 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892