Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke

Stroke Clinical Trial

Official title:

Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746525
• Other study ID #: R01NS063275
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: January 19, 2017
• Start date: September 2008
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Louis Stokes VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Surface functional electrical stimulation (FES)
FES is a technique that electrically stimulates a muscle in a comfortable manner in order to contract the muscle. It uses an electrode placed on the surface of the skin. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke.
• Motor learning
Motor learning is an exercise that uses movements needed for everyday tasks such as picking up a glass or opening a book. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke.
• Brain computer interface (BCI) training
BCI training uses signals produced by the brain to help individuals with stroke move their weak arm. This study will use BCI, FES and motor learning interventions to address upper extremity motor deficits following stroke.

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG (electroencephalography)	measures brain activity during a specified movement task	Week 12