Moving a Paralyzed Hand Through Use of a Brain-Computer Interface
Moving a Paralyzed Hand Through Use of a Brain-Computer Interface
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 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 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.
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 purpose of this protocol is to test the hypothesis that oscillatory brain
 activity that originates in the affected hemisphere in the form of desynchronization of
 Mu-rhythm of patients with chronic stroke or TBI can be used to drive movements of an
 orthosis attached to a paralyzed hand through a Brain Computer Interface (BCI). Mu-rhythm is
 a type of brain wave activity that originates in the sensorimotor areas of the brain that can
 be controlled voluntarily; it is present in the affected hemisphere of stroke patients and
 can be used to control the hand prostheses through the BCI interface. Control of Mu-rhythm
 amplitudes by volition requires training since it does not happen spontaneously. A
 proof-of-principle sub-experiment will test the hypothesis that in stroke survivors
 non-invasive cortical stimulation of the ipsilesional primary motor cortex (M1) will
 facilitate learning to control a hand orthosis through a BCI device. This is the purpose of
 the training: to teach the subject to control Mu-rhythms.

 Study population: The study population will consist of individuals with chronic stroke or TBI
 that have virtually no movement of their paretic hand and age- and gender- matched healthy
 volunteers. Healthy volunteers, which may include the age- and gender- matched volunteers,
 will be recruited to refine instructions given to patients.

 Design: This is primarily an intraindividual comparison study, designed to determine if this
 brain-computer interface (BCI) approach contributes to drive grasping motions through a BCI
 interface and hand-orthosis. To test the effect of non-invasive cortical stimulation 21
 stroke patients will be randomly assigned to three groups (group A, anodal stimulation; group
 B, cathodal stimulation; group C, sham stimulation). Study of normal volunteers will
 contribute to (a) set up of the experiment, (b) identifying differences in the training time
 required to modulate Mu-rhythm in healthy volunteers and patients and (c) to isolate training
 effects as measured by TMS and fMRI on the healthy brain from training effects on brains
 affected with stroke or TBI. This information will be treated descriptively within the
 framework of this protocol but it is also important for designing future studies.

 Outcome measures: Behavioral endpoint measure: ability to drive the paralyzed hand orthosis
 in flexion and extension motions using Mu-rhythm. Physiological endpoint measures: peak fMRI
 activity in the hand knob representation, and corticomotor excitability as tested with TMS
 and MEG in ipsilesional and contralesional hand knob representations. Normal volunteers will
 undergo evaluation of the same physiological endpoint measures as patients.
-  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.