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Completed

NCT Number: NCT00746525

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

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.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surface functional electrical stimulation (FES)

Other

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

Other

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

Other

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 outcomes

  1. EEG (electroencephalography)

    Time frame: Week 12

    measures brain activity during a specified movement task

Sponsors and collaborators

Lead sponsor

Louis Stokes VA Medical Center

Fed

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2008
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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