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NCT05642299
Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke (MBCI-SR)
Conditions: Stroke
Sex: All
Ages: 50 Years – 80 Years
Phase: NA
Enrollment: 10
Sponsor: Tan Tock Seng Hospital
Location: Singapore
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 Criteria:first ever stroke prior to clinical trialFugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66ability to give own consentability to pay attention and maintain supported sitting for 1.5 hours continuouslyable to comprehend and follow commandsfulfils BCI resting brain states on initial screeningunilateral upper limb impairmentExclusion Criteria:recurrent strokeinability to follow command and sit upright for 1.5 hourshemi-spatial neglectspasticity assessed by Modified Ashworth Scale more than 2/4History of EpilepsyFixed contracture / deformity of finger jointsupper limb pain impeding movements with visual analogy scale > 4/10Severe aphasia or cognitive impairment despite visual aidsother conditions ensuing upper limb weaknesspoor skin conditionsskull defect that might affect EEG or NIRS readingallergy to electrodes or adhesive gelsignificant vision and hearing impairment affecting participationPregnant women
Source: ClinicalTrials.gov (NCT05642299). StuddyBuddy aggregates publicly available trial information.