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

Recruiting

Phase N/A Results

Trial Description

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.

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.

Conditions

Interventions

  • Functional electrical stimulation (FES) Device
    Intervention Desc: 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.
  • Motor learning Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Stroke Experimental Group
    Description: Individuals in the stroke experimental group will receive treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.
  • Brain computer interface (BCI) training Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Stroke Experimental Group
    Description: Individuals in the stroke experimental group will receive treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.
  • Surface functional electrical stimulation (FES) assisted movement training Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Stroke Experimental Group
    Description: Individuals in the stroke experimental group will receive treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary FUGL-Meyer Coordination Scale; AMAT; EEG; fMRI
Secondary Strength testing, robotics testing, Wisconsin card sort, stroop.
Primary FUGL-Meyer Coordination Scale Week 12 No
Primary AMAT Week 12 No
Primary EEG (electroencephalography) Week 12 No
Primary fMRI (functional magnetic resonance imaging) week 12 No
Secondary strength testing Week 12 No
Secondary robotics testing week 12 No
Secondary Wisconsin Card Sort Week 12 No
Secondary Stroop Week 12 No

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