Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surface functional electrical stimulation (FES)
Motor learning
Brain computer interface (BCI) training
Sponsored by

About this trial
This is an interventional other trial for Stroke focused on measuring stroke, motor learning, rehabilitation of upper extremity, functional electrical stimulation, FES, brain computer interface, BCI, coordination, motor control
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)
Sites / Locations
- Malcom Randall VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brain Computer Interface Training Stroke Experimental Group
Arm Description
Individuals in the stroke experimental group received treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.
Outcomes
Primary Outcome Measures
EEG (electroencephalography)
measures brain activity during a specified movement task
Secondary Outcome Measures
Full Information
NCT ID
NCT00746525
First Posted
September 3, 2008
Last Updated
January 19, 2017
Sponsor
Louis Stokes VA Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00746525
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louis Stokes VA Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, motor learning, rehabilitation of upper extremity, functional electrical stimulation, FES, brain computer interface, BCI, coordination, motor control
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brain Computer Interface Training Stroke Experimental Group
Arm Type
Experimental
Arm Description
Individuals in the stroke experimental group received treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.
Intervention Type
Other
Intervention Name(s)
Surface functional electrical stimulation (FES)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Motor learning
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brain computer interface (BCI) training
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG (electroencephalography)
Description
measures brain activity during a specified movement task
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis J Daly, PhD, MS
Organizational Affiliation
Malcom Randall VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
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