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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT05642299
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

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

1. 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.

2. 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.

Study Timeline

• Study First Submitted: 2022-11-15
• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08
• Primary Completion: 2023-09-14
• Study Completion: 2023-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer score of upper limb	at week 24 (at 6 month post intervention)	a measure for upper extremity, movement coordination and reflex action.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	at week 24 ( at 6 months post intervention)	A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs

Trial Locations

Locations (1)

Tan Tock Seng Hospital Rehabilitation Centre; 🇸🇬 Singapore, Singapore