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

NCT00746525 | Completed

• 1 other identifier: R01NS063275
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• EEG (electroencephalography)

  measures brain activity during a specified movement task

  Week 12

Study Arms (1)

Brain Computer Interface Training Stroke Experimental Group

EXPERIMENTAL

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); Other: Motor learning; Other: Brain computer interface (BCI) training

Interventions

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.

Brain Computer Interface Training Stroke Experimental Group

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 Training Stroke Experimental Group

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.

Brain Computer Interface Training Stroke Experimental Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medically stable and \>/= 6 months post stroke
• difficulty using upper limb for functional tasks
• \>21 years old

You may not qualify if:

• chronic, progressive medical condition (i.e. Parkinson's disease)

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Brain-Computer Interfaces; 2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Janis J Daly, PhD, MS

  Malcom Randall VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Brain Rehabilitation Research Center

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

US (1)