NCT05642299

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	MBCI-SR	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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-09-14
• Completion: 2023-12-14
• First posted: 2022-12-08
• Last updated: 2022-12-08

Locations

1 site across 1 country: Singapore