Clinical trial NCT00746525: Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
Official title: Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
motor learning
rehabilitation of upper extremity
functional electrical stimulation
FES
brain computer interface
BCI
coordination
motor control
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-09-04
Enrollment: 8
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this trial was to evaluate the benefits of combination motor learning training and brain computer interface training for restoring arm function in people with stroke. Our aim was to determine whether the surface-acquired brain signal (electroencephalography (EEG)) can feasibly be used as a neural feedback system to drive more normal motor function in stroke survivors.

Detailed description: 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.

Eight people who had a stroke were enrolled in the experimental group. They received brain signal training and comprehensive motor learning based therapy.

An additional 5 healthy adults were 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 attempted.

Eligibility 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)

Primary outcomes:
measure: EEG (electroencephalography)
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
Study officials:
affiliation: Malcom Randall VA Medical Center
name: Janis J Daly, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: