Skip to main content
Clinical Trials/NCT02552368
NCT02552368
Completed
Not Applicable

A Brain Computer Interface and Brain-Controlled Stroke Rehabilitation Method Utilizing Electroencephalography in Hemiparetic and Hemiplegic Stroke Patients to Achieve Thought Control of Machines and a Better Understanding of Brain Function

Washington University School of Medicine1 site in 1 country23 target enrollmentAugust 2012
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Washington University School of Medicine
Enrollment
23
Locations
1
Primary Endpoint
Change in Action Research Arm Test (ARAT) Score
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

Detailed Description

This study will be carried out in two phases designed to achieve the objectives described above. The first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. This phase will involve recording EEG signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. After recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to determine the accompanying EEG signals. The EEG signals would then be used to control stimulation of the impaired limb. Rehabilitation would be assessed by examining changes in commonly used functional motor scores. The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
November 30, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 6 months post stroke
  • Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity
  • Short Blessed Test Score of 8 or less
  • Unstructured Mesulam with 2 or less omissions

Exclusion Criteria

  • Severe spasticity in affected upper extremity
  • Unilateral Visual Inattention (neglect)
  • Contracture(s) in the affected upper extremity
  • Botox injections administered within 9 months
  • Aphasia which limits effective communication

Outcomes

Primary Outcomes

Change in Action Research Arm Test (ARAT) Score

Time Frame: Baseline and 12 weeks

The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation (Platz, Pinkowski, Kim, di Bella, \& Johnson, 2005). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test The maximum score achievable on this measure is 57 points.

Secondary Outcomes

  • Canadian Occupational Performance Measure (COPM)(Baseline and 12 weeks)

Study Sites (1)

Loading locations...

Similar Trials