BCIwiki (bciwiki.com) — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology has registered a multicenter cohort study in the Chinese Clinical Trial Registry to evaluate non-invasive brain-computer interface treatment for stroke and functional remodeling, under registration number ChiCTR2600130037, registered on August 13, 2026. The study plans to enroll 1,000 stroke patients, 500 in the treatment arm receiving closed-loop BCI plus functional electrical stimulation (BCI-FES) rehabilitation training and 500 in the control arm receiving conventional rehabilitation training. First enrollment is scheduled for September 1, 2026, and the recruitment status is not yet recruiting.
The study enrolls patients aged 18 to 80 with ischemic or hemorrhagic stroke confirmed by MRI or CT, unilateral upper and/or lower limb motor dysfunction, an NIHSS motor score of 1 for the affected limb at enrollment, stable vital signs, and the ability to cooperate with sitting or semi-reclining training. Exclusion criteria include severe aphasia or cognitive impairment, a history of epilepsy or seizures after admission, sensory disorders or hallucinations, apraxia, agnosia, and contraindications to FES such as metal internal fixation devices or cardiac pacemakers in the affected limb.
The primary endpoint is 2-week change in FMA-LE and FMA-UE scores after enrollment. Secondary endpoints include change from baseline in FMA-LE and FMA-UE scores at 12 weeks, distribution of mRS scores at 12 weeks, and change from baseline at 2 weeks in 10MWT gait speed, MAS score, BBS score, ARAT score, WMFT score, FAC score, TUG time, and IADL score. The study is an observational cohort study, phase 4, funded by self-financing, with the registry record last updated on August 24, 2026.