NCT00242242

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

Terminated Last updated 25 November 2019

What this trial tests

trial in Stroke in 110 participants. Terminated before completion.

Timeline

17 October 2005

23 July 2013

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	110
Start date	17 October 2005
Estimated completion	23 July 2013
Sites	1 location across United States

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 80, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.