Moving a Paralyzed Hand Through Use of a Brain-Computer Interface

Stopped early

Conditions studied: Stroke

In brief

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.

Key facts

Study ID: NCT00242242
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 110
Starts: 2005-10-17
Expected to finish: 2013-07-23
Last updated by the study team: 2019-11-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

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.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.