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

• ClinicalTrials.gov Identifier: NCT00746525
• Recruitment Status: Completed
• First Posted: September 4, 2008
• Last Update Posted: January 23, 2017
• Sponsor: Louis Stokes VA Medical Center
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): Janis Daly, North Florida/South Georgia Veterans Health System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Other: Surface functional electrical stimulation (FES); Other: Motor learning; Other: Brain computer interface (BCI) training	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
• Study Start Date: September 2008
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: Brain Computer Interface Training Stroke Experimental Group; Individuals in the stroke experimental group received treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.

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.; Other: 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.; Other: 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.

Outcome Measures

Primary Outcome Measures :

1. EEG (electroencephalography) [ Time Frame: Week 12 ]
   measures brain activity during a specified movement task

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Florida

Malcom Randall VA Medical Center

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

Louis Stokes VA Medical Center

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

More Information

• Responsible Party: Janis Daly, Director, Brain Rehabilitation Research Center, North Florida/South Georgia Veterans Health System
• ClinicalTrials.gov Identifier: NCT00746525
• Other Study ID Numbers: R01NS063275 ( U.S. NIH Grant/Contract )
• First Posted: September 4, 2008
• Last Update Posted: January 23, 2017
• Last Verified: January 2017

Keywords provided by Janis Daly, North Florida/South Georgia Veterans Health System:

stroke; motor learning; rehabilitation of upper extremity; functional electrical stimulation; FES; brain computer interface; BCI; coordination; motor control

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases