EEG Based BCI for Upper Limb Rehabilitation in Stroke

December 4, 2019 updated by: Subasree Ramakrishnan, University of Houston

EEG Based Brain Computer Interface in Chronic Stroke Survivors for Upper Limb Rehabilitation- A Pilot Study Using Motor Execution and Motor Imagery

Biomedical and Engineering approaches form a key element to neurological rehabilitation of upper limbs. Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke.

The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke.

The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability. Studies have shown that movement and motor imagery (MI) (i.e., the mental rehearsal of a movement without any activation of the muscles) induce similar EEG patterns over the motor cortex.

Movement execution, preparation and even observation are usually accompanied by a decrease in µ- and β-rhythm in the cortical area representing the involved body segment. Such a reduction is called event-related desynchronization (ERD).The increase in µ-rhythm, i.e. event-related synchronization (ERS), is observed in the regions of the brain representing body segments, which are not involved in the task.This study is a pilot study to examine the feasibility of a SMR based EEG BCI using motor task and motor imagery and involve a gaming feedback for same.

The first two days will be used for calibrating the BMI using commands in computer screen followed by further two days for testing the BMI and feedback control during gaming in computer to move the ball in the computer screen.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77025
        • Recruiting
        • Subasree Ramakrishnan
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Andrew Paek, RA
        • Sub-Investigator:
          • Akshay Ravindran, RA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • age: 21-75 years

    • Subacute or chronic stroke; interval of at least 3 months and interval of at least 6 months from stroke to time of enrollment, respectively.
    • no cerebellar signs or bilateral motor deficit
    • Cognitive ability to consent, assimilate, and participate actively in the treatment protocol (Mini Mental State Examination score > 24 points, out of a total 30 indicating normal cognitive ability);
    • Modified Rankin scale scores 1-3 (Mild-Moderate functional disability post-stroke);
    • Modified Ashworth Scale of Spasticity score <= 3 (ranges from 0-4 with 4 reflecting maximum spasticity)

    • No epilepsy /usage of antiepileptic drug

      ◦ Subjects with Stroke will be included if they have:

    • unilateral impaired upper limb
    • Able to initiate hand movements like opening and closing fist and no joint contracture or severe spasticity in the affected upper limbs.
    • Sufficient sitting balance to participate in experimental activities.
    • No condition (e.g. severe arthritis, central pain) that would interfere with the administration of motor function tests.
    • English-language comprehension and cognitive ability sufficient to give informed consent (MMSE >=24) and to cooperate with the intervention.

Exclusion Criteria:

  • • Orthopedic conditions of either upper or lower extremity that would affect performance on the study

    • untreated depression that may affect motivation to participate in the study
    • vascular cognitive impairment interfering with comprehending the tasks
    • Individuals with stroke who have been diagnosed with cognitive or severe visual deficits, hemineglect, uncontrolled angina, or pregnancy

    • no psychiatric or neurological condition other than stroke

      ◦ Stroke will be excluded if they have:

    • Pregnancy (Self -reported)
    • Dementia (MMSE score less than 24)
    • Recurrence of stroke (Occurrence of new focal deficits reported by patient or detected by PI on examination during visits)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EEG BCI closed loop feedback for rehabilitation of upper limb

This study is a pilot study to examine the feasibility of a SMR based EEG BCI using motor task and motor imagery and involve a gaming feedback for same.

The first two days will be used for calibrating the BMI using commands in computer screen followed by further two days for testing the BMI and feedback control during gaming in computer to move the ball in the computer screen.
Other: EEG -BCI based Feedback for rehabilitation
Subjects will undergo EEG based BCI as feedback for rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66)
Time Frame: 4 days
Change in Hand strength
4 days
Decoding motor intent of hand movements using Scalp Electroencephalography(EEG)
Time Frame: 4 days
Electroencephalographic spectral power changes during Motor execution and Motor Imagery of hand movements in stroke subjects
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Houston

Investigators

  • Principal Investigator: Subasree R, University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2019

Primary Completion (ANTICIPATED)

January 31, 2020

Study Completion (ANTICIPATED)

January 31, 2020

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (ACTUAL)

December 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently not planning for data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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