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BCI for Hemiparetic Upper Extremities in Patients Due to Stroke

Primary Purpose

Stroke, Brain Computer Interface

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Brain Computer Interface, Neurorehabilitation, Event Related Desynchronization

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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; Between 18 and 64 years old; With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 4 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.)

Sites / Locations

  • The Hong Polytechnic University, Department of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

BCI-FES-VR

BCI-FES

BCI-VR

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
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.
Change from Baseline Action Research Arm Test (ARAT)
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 Outcome Measures

Revised Purdue Spatial Visualization Test (Revised PSVT:R)
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.
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
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.
Hand grip strength test
It is a measure of muscular strength or the maximum force/tension generated by the participant's forearm muscles.
Motor Activity Log (MAL)
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.

Full Information

First Posted
January 31, 2023
Last Updated
September 21, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05778448
Brief Title
BCI for Hemiparetic Upper Extremities in Patients Due to Stroke
Official Title
Brain-computer Interface (BCI) Based Closed-loop Training for Hemiparetic Upper Extremities in Patients Due to Stroke: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Brain Computer Interface
Keywords
Stroke, Brain Computer Interface, Neurorehabilitation, Event Related Desynchronization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCI-FES-VR
Arm Type
Experimental
Arm Description
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.
Arm Title
BCI-FES
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BCI-VR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Description
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.
Time Frame
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Title
Change from Baseline Action Research Arm Test (ARAT)
Description
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)
Time Frame
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Secondary Outcome Measure Information:
Title
Revised Purdue Spatial Visualization Test (Revised PSVT:R)
Description
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.
Time Frame
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Title
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Description
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.
Time Frame
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Title
Hand grip strength test
Description
It is a measure of muscular strength or the maximum force/tension generated by the participant's forearm muscles.
Time Frame
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Title
Motor Activity Log (MAL)
Description
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.
Time Frame
Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Between 18 and 64 years old; With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 4 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.)
Facility Information:
Facility Name
The Hong Polytechnic University, Department of Rehabilitation Sciences
City
Hong Kong
ZIP/Postal Code
Hung Hom
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32334608
Citation
Bai Z, Fong KNK, Zhang JJ, Chan J, Ting KH. Immediate and long-term effects of BCI-based rehabilitation of the upper extremity after stroke: a systematic review and meta-analysis. J Neuroeng Rehabil. 2020 Apr 25;17(1):57. doi: 10.1186/s12984-020-00686-2.
Results Reference
background
PubMed Identifier
28003656
Citation
Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22. Erratum In: Nat Rev Neurosci. 2019 May;20(5):314.
Results Reference
background
Citation
Cruz Gonzalez, P., Fong, K. N., & Brown, T. (2022). Closed-Loop Brain-Computer Interface Training for Hemiparetic Upper Extremities in Patients with Chronic Stroke: A randomized control study [Abstract]. Neurorehabilitation and Neural Repair. Poster presentation at the 12th World Congress for Neurorehabilitation, December 2022, Vienna, Austria.
Results Reference
background

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BCI for Hemiparetic Upper Extremities in Patients Due to Stroke

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