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

Stroke Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT05642299
• Study type: Interventional
• Source: Tan Tock Seng Hospital
• Contact: Chloe Lauha Chung, PhD
• Phone: +65 6357 8305
• Email: chloe_lh_chung@ttsh.com.sg
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Completion date: December 14, 2023