Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke (MBCI-SR)

Study Overview
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Brief Summary
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One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer Motor Assessment (FMA-UE)score in chronic stroke patients that is significantly better than standard care. However, all the stroke patients underwent the same one-size-fits-all treatment option involving all six different activities of daily living (ADL)-oriented tasks regardless of their impairment or ability. Investigators hypothesize that precision personalized stroke rehabilitation intervention that is tailored to the patient hold more promise than a one-size-fits-all stroke rehabilitation strategy.

Detailed Description
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To address the one-size-fits-all stroke rehabilitation strategy, RRIS will develop an Ability data-driven personalized stroke rehabilitation based on the stroke patient's UL impairment and motor ability, by first matching 6 UL tasks in RRIS Ability Database with the 6 ADL tasks of the BCI-SR Intervention via similarity indices. A personalized subset of ADL tasks treatment options is then generated by a data-driven recommendation based on the patient's ability, movement pattern of the treatment option and the normative data from the RRIS Ability Database. A multi-modal BCI is proposed to perform EEG subject-specific calibration using Near-infrared spectroscopy, NIRS to ensure motor imagery compliance. stroke subjects with UL impairments (score 11-45 on the FMA-UE) will be recruited to undergo the UL tasks assessment at RRIS. They will then undergo the personalized stroke rehabilitation using the Multimodal EEG and NIRS-based BCI with Soft Robotic therapy for 1.5 hour over 6 weeks, 3 times a week. The effectiveness of the personalized stroke rehabilitation can then be retrospectively compared to the use of one-size-fits-all ADL tasks in the previous clinical trial.

Official Title
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Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: MBCI-SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first ever stroke prior to clinical trial Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66 ability to give own consent ability to pay attention and maintain supported sitting for 1.5 hours continuously able to comprehend and follow commands fulfils BCI resting brain states on initial screening unilateral upper limb impairment Exclusion Criteria: recurrent stroke inability to follow command and sit upright for 1.5 hours hemi-spatial neglect spasticity assessed by Modified Ashworth Scale more than 2/4 History of Epilepsy Fixed contracture / deformity of finger joints upper limb pain impeding movements with visual analogy scale > 4/10 Severe aphasia or cognitive impairment despite visual aids other conditions ensuing upper limb weakness poor skin conditions skull defect that might affect EEG or NIRS reading allergy to electrodes or adhesive gel significant vision and hearing impairment affecting participation Pregnant women

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCI-SR<br>BCI based robotic rehabilitation works by detecting the motor intent of the user from Electroencephalogram signals to drive rehabilitation assisted by the soft robotics gloves. | Device: MBCI-SR<br>* Participants will be asked to wear and EEG+NIRS cap and a soft robotic glove on their stroke-impaired hand. The participant will be instructed to ask to imagine to picture moving the stroke-imparied hand in the mind. The brain signal (EEG and NIRS data) will be recorded as a reference. When the participant pictures this move again, upon detection of such imagined move by MBCI-SR system, the glove will be activated and assists the participants to perform a specific upper limb task based on individual ability. There are six different activities of daily living (ADL)-oriented tasks enacted through a virtual arm and virtual objects, which formed the visual feedback for the participants. These tasks include scanning goods, moving an object upward to a cabinet, using two hands to move a towel, pouring of water into a cup, eating action and fine motor movement of picking up a small block using two fingers. Training intensity is 1.5 hours for 3 times a week for 6 weeks, a total of 18 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer score of upper limb | a measure for upper extremity, movement coordination and reflex action. | Baseline | 
| Fugl-Meyer score of upper limb | a measure for upper extremity, movement coordination and reflex action. | at week 4 (mid point) | 
| Fugl-Meyer score of upper limb | a measure for upper extremity, movement coordination and reflex action. | at week 6 (completion of intervention) | 
| Fugl-Meyer score of upper limb | a measure for upper extremity, movement coordination and reflex action. | at week 12 (at 3 month post intervention) | 
| Fugl-Meyer score of upper limb | a measure for upper extremity, movement coordination and reflex action. | at week 24 (at 6 month post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs | Baseline | 
| Action Research Arm Test | A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs | at week 12 (at 3 months post intervention) | 
| Action Research Arm Test | A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs | at week 24 ( at 6 months post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain-Computer Interface; upper limb rehabilitation