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

Last updated: December 7, 2022
Sponsor: Tan Tock Seng Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05642299
2021/00715
  • Ages 50-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • first ever stroke prior to clinical trial
  • Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximumscore 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

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

Total Participants: 10
Study Start date:
December 01, 2022
Estimated Completion Date:
December 14, 2023

Study 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.

Connect with a study center

  • Tan Tock Seng Hospital Rehabilitation Centre

    Singapore, 569766
    Singapore

    Active - Recruiting

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