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NCT Number: NCT05778448

BCI for Hemiparetic Upper Extremities in Patients Due to Stroke

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Polytechnic University, Department of Rehabilitation Sciences

Hong Kong, Hung Hom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain CT or MRI;
  • Chronic phase of stroke, i.e., time after stroke onset more than 6 months;
  • ≥ 18 years old;
  • 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)
  • Able to give informed written consent to participate in the study.

Exclusion criteria

  • Previous diagnosis of any neurological disease excluding stroke;
  • Presence of any sign of cognitive problems (Abbreviated Mental Test < 6)
  • 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
  • With other notable impairments of the upper extremity not caused by stroke (e.g., fracture, Rheumatoid Arthritis, or congenital deformity, etc.)

Treatment and study plan

Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality

Device

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).

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
Jun 8, 2026

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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