Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
The purpose of this trial is to evaluate the benefits of motor learning, functional electrical stimulation, and brain computer interface training for restoring arm function in people with stroke.
The financial burden and human suffering are devastating after stroke due to the lack of rehabilitation protocols that can restore normal brain and motor function. Conventional treatment does not restore normal motor function to many stroke survivors. The majority of available treatments are directed at the peripheral nervous system (arms/legs). Since stroke occurs in the brain and results in brain damage and dysfunction, a more direct approach may be to re-train the brain by directly treating the activation of brain signals that control movement.
The purposes of this study are to determine if motor learning, functional electrical stimulation (FES), and brain computer interface (BCI) training are beneficial for restoring arm function in people who have had a stroke, and to determine if the surface-acquired brain signal [electroencephalography (EEG)] can be re-trained to provide more normal motor function in stroke survivors. The primary purpose of this study is to determine the efficacy of the motor learning tasks in stroke recovery.
In the study, scientists will use two different and complimentary brain signal training components to restore more normal motor control of a motor task (elbow, wrist, or finger movement task). Specifically targeting, invoking, and training the surface-acquired EEG brain signal, and integrating brain signal training into motor learning training of upper limb motor tasks, may result in greater motor restoration when compared to a comprehensive motor learning intervention without EEG brain signal training.
Thirty six people who have had a stroke will be enrolled in the experimental group. They will receive brain signal training and be assigned to one of three groups: elbow coordination impairment; wrist impairment; or finger coordination impairment. The BCI training will focus on the movement impairment for each group, respectively. Treatment will be 5 hours a day, 5 days a week, for 12 weeks, based on prior established motor learning protocols. A single day—5-hour session—will be composed of the following: up to 1 hour of brain signal training; up to 1.5 hours of FES-assisted movement practice; and up to 2.5 hours of motor learning.
Up to an additional 30 healthy adults will be enrolled in order to study their ability to acquire brain signal control and the characteristics of their brain signal during the tasks that the stroke participants will attempt.
Directly and effectively treating the brain (where the stroke occurred) has the potential to shorten rehabilitation time, reduce therapist/patient ratio, more completely restore motor function, restore motor function to a higher percentage of patients after stroke, and the method may possibly be applicable to other neurological diagnoses.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Surface functional electrical stimulation (FES) assisted movement training, Motor learning, Brain computer interface (BCI) training
Louis Stokes Cleveland Department of Veterans Affairs Medical Center, 10701 East Blvd., Mailstop 151-W
Louis Stokes VA Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00746525
- Information obtained from ClinicalTrials.gov on July 15, 2010
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Medical and Biotech [MESH] Definitions
The electrical response evoked in a muscle or motor nerve by electrical or magnetic stimulation. Common methods of stimulation are by transcranial electrical and TRANSCRANIAL MAGNETIC STIMULATION. It is often used for monitoring during neurosurgery.
Proteins that are involved in or cause CELL MOVEMENT such as the rotary structures (flagellar motor) or the structures whose movement is directed along cytoskeletal filaments (MYOSIN; KINESIN; and DYNEIN motor families).
Therapy assisted by the use of a horse and/or its movement, including equine-assisted psychotherapy, horseback riding, and hippotherapy.
The recorded electrical responses from nerve, muscle, SENSORY RECEPTOR, or area of the CENTRAL NERVOUS SYSTEM following stimulation. They range from less than a microvolt to several microvolts. The evoked potential can be auditory (EVOKED POTENTIALS, AUDITORY), somatosensory (EVOKED POTENTIALS, SOMATOSENSORY), visual (EVOKED POTENTIALS, VISUAL), or motor (EVOKED POTENTIALS, MOTOR), or other modalities that have been reported. Often used synonymously to event-related potentials which are associated with higher level cognitive processes.
A technique in assisted reproduction (REPRODUCTIVE TECHNIQUES, ASSISTED) consisting of hormonal stimulation of the ovaries, follicular aspiration of preovulatory oocytes, in-vitro fertilization, and intrafallopian transfer of zygotes at the pronuclear stage (before cleavage).