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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Louis Stokes VA Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janis Daly, North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier:
NCT00746525
First received: September 3, 2008
Last updated: February 23, 2014
Last verified: February 2014
  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.


Condition Intervention
Stroke
Other: Surface functional electrical stimulation (FES) assisted movement training
Other: Motor learning
Other: Brain computer interface (BCI) training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke

Resource links provided by NLM:


Further study details as provided by Louis Stokes VA Medical Center:

Primary Outcome Measures:
  • FUGL-Meyer Coordination Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    a measure of a persons ability to perform coordinated movements of the upper limb

  • AMAT [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    a measure of ability to perform everyday tasks i.e. eating, drinking from a cup

  • EEG (electroencephalography) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    measures brain activity during a specified movement task

  • fMRI (functional magnetic resonance imaging) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    imaging test measuring changes in brain structure


Secondary Outcome Measures:
  • strength testing [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    measure of individual muscle strength of the muscles of the upper limb

  • robotics testing [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    measure of elbow/shoulder coordination

  • Wisconsin Card Sort [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    a measure of cognitive function

  • Stroop [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    a measure of attention conflict resolution


Estimated Enrollment: 66
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stroke Experimental Group
Individuals in the stroke experimental group will receive treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.
Other: Surface functional electrical stimulation (FES) assisted movement training
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.

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.

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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746525

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

Locations
United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Carolyn Hanson, Ph.D., OTR    352-376-1611 ext 5110    carolyn.hanson@va.gov   
Principal Investigator: Janis J Daly, PhD, MS         
Sponsors and Collaborators
Louis Stokes VA Medical Center
Investigators
Principal Investigator: Janis J Daly, PhD, MS Malcom Randall VA Medical Center
  More Information

No publications provided

Responsible Party: Janis Daly, Director, Brain Rehabilitation Research Center, North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier: NCT00746525     History of Changes
Other Study ID Numbers: R01NS063275
Study First Received: September 3, 2008
Last Updated: February 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Louis Stokes VA Medical Center:
stroke
motor learning
rehabilitation of upper extremity
functional electrical stimulation
FES
brain computer interface
BCI
coordination
motor control

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014