BCI for Hemiparetic Upper Extremities in Patients Due to Stroke

June 4, 2026 updated by: Kenneth N. K. Fong, The Hong Kong Polytechnic University

Brain-computer Interface (BCI) Based Closed-loop Training for Hemiparetic Upper Extremities in Patients Due to Stroke: A Randomized Controlled Study

Non-invasive brain-computer interface (BCI) technology is one of the new training approaches to achieve motor restoration through a closed-loop system from brain activity through event-related desynchronization (ERD) after motor imagery (MI) or movement attempt to peripheral feedback triggered by an external hepatic device. Often, it is unclear whether the BCI intervention itself or the assistance of the external device leads to neural responses and functional gains.

This study adopts a closed-loop BCI system involving ERD induced by MI. Functional electrical stimulation (FES) and virtual reality (VR) are simultaneously delivered as feedback. The aim is to investigate the efficacy of closed-loop BCI training combined with FES and VR on the recovery of the hemiparetic upper extremity of individuals with chronic stroke.

Chronic stroke survivors are being recruited and randomly allocated into 3 groups: (1) BCI-FES-VR - participants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered; (2) BCI-FES - same procedure as group 1, but the difference is that the participant's hands replace the VR system; (3) BCI-VR - same procedure as group 1, but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.

Motor and MI assessments are being conducted at post-assessment and at a 3-week follow-up.

The findings of this study will provide significant new information regarding neurophysiological motor relearning mechanisms, which could inform the development and evaluation of BCI-based treatment for individuals with stroke and impact the field of translational neuroscience.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, Hung Hom
        • The Hong Polytechnic University, Department of Rehabilitation Sciences

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

18 years to 64 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain CT or MRI;
  2. Chronic phase of stroke, i.e., time after stroke onset more than 6 months;
  3. ≥ 18 years old;
  4. With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 5 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE)
  5. Able to give informed written consent to participate in the study.

Exclusion Criteria:

  1. Previous diagnosis of any neurological disease excluding stroke;
  2. Presence of any sign of cognitive problems (Abbreviated Mental Test < 6)
  3. Modified Ashworth score > 2 in wrist extensor muscle in the hemiparetic upper extremity after stroke (Bohannon and Smith, 1987) or with severe pain that hinders upper extremity movement
  4. With other notable impairments of the upper extremity not caused by stroke (e.g., fracture, Rheumatoid Arthritis, or congenital deformity, etc.)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCI-FES-VR
Participants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.
Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
A BCI system involves 3 main components - (1) brain activity collection, (2) external devices triggered by specific features of brain activity, and (3) a processor which decodes the brain activity signal and then translates it into computerized commands to control external devices such as virtual games and functional electrical stimulation (FES).
Active Comparator: BCI-FES
Same procedure as arm 1 (BCI-FES-VR), but the difference is that the participant's hands replace the VR system. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.
Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
A BCI system involves 3 main components - (1) brain activity collection, (2) external devices triggered by specific features of brain activity, and (3) a processor which decodes the brain activity signal and then translates it into computerized commands to control external devices such as virtual games and functional electrical stimulation (FES).
Active Comparator: BCI-VR
Same procedure as arm 1 (BCI-FES-VR), but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.
Device: Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
A BCI system involves 3 main components - (1) brain activity collection, (2) external devices triggered by specific features of brain activity, and (3) a processor which decodes the brain activity signal and then translates it into computerized commands to control external devices such as virtual games and functional electrical stimulation (FES).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time Frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
FMA-UE is a clinical assessment for upper limb motor impairment after stroke. It includes 33 items assessing the movement, coordination, and reflex actions of the shoulder, elbow, forearm, and wrist, and the hand joints of the hemiparetic arm. Each item consists of a 3-point ordinal scale (0, 1 and 2), with a total score of 66. The higher the score, the better the performance.
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Change from Baseline Action Research Arm Test (ARAT)
Time Frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
The ARAT is a clinical assessment for upper limb functional activities for patients with stroke. The ARAT assesses proximal and distal components of upper limb function. It consists of four subscales: grasp, grip, pinch, and gross movement. It has 19 movement tasks, each graded using a four-point ordinal scale (total scores range from 0 to 57)
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Purdue Spatial Visualization Test (Revised PSVT:R)
Time Frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

This test consists of 30 questions designed to see how well a participant can visualize the rotation of three-dimensional objects.

objects. Each correct answer scores 1 point. The total score is 30 points. The higher the score, the better the performance.
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time Frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
The aim of this questionnaire is to determine the extent to which individuals are able to visualize and feel imagined movements. All movements are assessed from a sitting position. The questionnaire includes a visual imagery scale and a kinesthetic imagery scale. The long version (KVIQ-20) comprises 20 items (10 movements for each scale). The rating scale is a 5-point ordinal scale, the clarity of the visual image ( Items V1 to V10) or the intensity of the sensations associated with the imagined movement (Items K1 to K10). The higher the score, the better the outcome. The highest score is 50.
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Hand grip strength test
Time Frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
It is a measure of muscular strength or the maximum force/tension generated by the participant's forearm muscles.
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Motor Activity Log (MAL)
Time Frame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
It is a subjective measure of an individual's real life functional upper limb performance and consists of two scales: the amount of use and quality of movement. The MAL adopts a 6-point ordinal scale from 0 to 5. The higher the score, the better the outcome.
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

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)

August 11, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCI_KennethFong_PabloCruz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Stroke

Clinical Trials on Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe