Protocol Number: 06-N-0012

Title:

Moving a Paralyzed Hand through a Brain-Computer Interface Controlled by the Affected Hemisphere After Stroke

Number:

06-N-0012

Summary:

This study will gain information on methods of control of a prosthetic arm in stroke patients through a technique called "brain-computer interface" (BCI). BCI allows for direct communication between man and machine. Brain cells communicate by producing electrical impulses that help to create such things as thoughts, memory, consciousness and emotions. In BCI, brain waves are recorded by an electroencephalogram (EEG) through electrodes (small wires) attached to the scalp. The electrodes measure the electrical signals of the brain. These signals are sent to the computer, which translates them into device control commands as messages that reflect a person's intention. This type of brain activity comes from the sensorimotor areas of the brain and can be controlled through voluntarily training to control the hand prosthesis through the BCI.

Healthy normal volunteers and people who have had a stroke 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.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA - CHRONIC STROKE PATIENTS:

Between the ages of 18 and 80 years.

At least 12 months post thromboembolic non-hemorrhagic hemispheric or hemorrhagic hemispheric subcortical lesions.

Substantial unilateral motor impairment, defined by MRC scores less than or equal to 2.

EXCLUSION CRITERIA - CHRONIC STROKE PATIENTS:

History of alcohol or drug abuse.

History of epilepsy.

Cerebellar lesions.

More than one stroke in the middle cerebral artery territory.

Bilateral motor impairment.

Uncontrolled medical problems (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.

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.

Pregnancy

MRI contraindications.

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.

INCLUSION CRITERIA - HEALTHY VOLUNTEERS:

Between the ages of 18 and 80 years

EXCLUSION CRITERIA - HEALTHY VOLUNTEERS:

Inability to perform study tasks.

Uncontrolled medical problem.

History of epilepsy.

History of alcohol or drug abuse or psychiatric illness.

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.

Pregnancy.

MRI contraindications.

Cardiac pacemakers.

Intracardiac lines.

Implanted medication pumps.

Neural stimulators; eye, blood vessel, cochlear, or eye implants; with 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 make a 12-week commitment.

Special Instructions:

Currently Not Provided

Keywords:

Stroke

BCI

Recruitment Keyword(s):

Stroke

Healthy Volunteer

HV

Condition(s):

Stroke

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

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

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8.

Dobkin BH. Driving cognitive and motor gains with rehabilitation after brain and spinal cord injury. Curr Opin Neurol. 1998 Dec;11(6):639-41. No abstract available.

Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36.

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