Gainesville, Florida 32608


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - medically stable and >/= 6 months post stroke - difficulty using upper limb for functional tasks - >21 years old Exclusion Criteria: - chronic, progressive medical condition (i.e. Parkinson's disease)


NCT ID:

NCT00746525


Primary Contact:

Principal Investigator
Janis J Daly, PhD, MS
Malcom Randall VA Medical Center

Carolyn Hanson, Ph.D., OTR
Phone: 352-3761611 ext. 5110
Email: carolyn.hanson@va.gov


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32608
United States

Carolyn Hanson, Ph.D., OTR
Phone: 352-376-1611
Email: carolyn.hanson@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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