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Moving a Paralyzed Hand through a Brain-Computer Interface Controlled by the Affected Hemisphere After stroke or Traumatic Brain Injury
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
06-N-0012 |
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 |
stroke; |
Recruitment Keyword(s) |
stroke; |
Condition(s) |
stroke |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Healthy normal volunteers and people who have had a stroke or traumatic brain injury more than 12 months ago and have paralysis in the right or left arm, hand or leg and who are between 18 and 80 years of age may be eligible for this study. Candidates are screened with a clinical and neurological examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the procedure, the subject lies in the scanner for about 45 minutes, wearing ear plugs to muffle loud knocking sounds that occur with the scanning.
Participants undergo the following procedures:
-Sessions 1-2: Participants are connected to an EEG machine and familiarized with the hand orthosis (training device used in the study) and the tasks required for the study.
-Sessions 3-4: Participants receive baseline transcranial magnetic stimulation (TMS) and fMRI. For TMS, a wire coil is held on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject may feel a pulling sensation on the skin under the coil and there may be twitching in muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms. fMRI is like a standard MRI (see above), except it is done while the patient performs tasks to learn about brain activity involved in those tasks.
-Sessions 5-8: Participants are asked to repetitively move their hand (patients' paralyzed hand; healthy volunteers' normal hand), tongue and leg in response to three sound tones. After ten trials, they are asked to imagine the same movements 50 to 100 times while the EEG machine is recording brain activity.
-Sessions 9-14: Participants are trained in controlling the hand orthosis. The subject's hand is attached to the orthosis and asked to imagine that they are performing finger or hand movements. This continues until there is an 80-90 percent success rate in achieving hand movement.
-Sessions 15-16: Participants repeat TMS and fMRI for comparison before and after training with the hand orthosis.
-Sessions 17-28: Participants receive additional training with the hand orthosis device (as in sessions 5-8), focusing only on the hand and not other parts of the body.
-Sessions 29-30: Participants undergo repeat TMS and fMRI to compare with the effect following additional training with the hand orthosis.
-Sessions 31-32: Optional makeup sessions if needed because of scheduling problems.
Participants are evaluated in the clinic after 3 months to see if they have benefited from the study.
Eligibility
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.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Leonardo G. Cohen, M.D. National Institute of Neurological Disorders and stroke (NINDS) National Institutes of Health BG 10 RM 7D54 MSC 1428 10 CENTER DR BETHESDA MD 20892-1428 (301) 496-9782 cohenl1@mail.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:
NCT00242242
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