BCIwiki (bciwiki.com) — A BCI rehabilitation trial sponsored by Huashan Hospital, Fudan University has been completed, with 54 stroke patients who have upper-limb hand impairment split into three groups receiving BCI training based on kinesthetic motor imagery, hybrid motor imagery and visuomotor imagery. The trial is registered with the Chinese Clinical Trial Registry under ChiCTR2600124660, with a registration date of May 15, 2026 and a first-enrolment date of March 18, 2025.
Each group was planned to enroll 18 patients aged 25 to 80, with no gender restriction. Inclusion required a disease course of 7 days to 6 months and ongoing rehabilitation training, a Kinesthetic and Visual Imagery Questionnaire (KVIQ-20) score of at least 55 and a Mini-Mental State Examination (MMSE) score of at least 20. Exclusions included use of drugs affecting muscle tone within 1 month, metal implants in the skull, a history of epilepsy or seizures within the past 2 years, and contraindications to transcranial magnetic stimulation.
The trial uses an interventional, parallel design. The primary outcome is the upper-limb Fugl-Meyer score; secondary outcomes include the Box and Block Test, ARAT motor function assessment, the Modified Nottingham Sensory Function Assessment Scale, the National Institutes of Health Stroke Scale (NIHSS), the Ashworth Rating, the modified Barthel index, the Schulte square test, the Montreal Cognitive Assessment (MoCA) and a mental rotation test. Funding is self-funded.
The registration record was last updated on May 18, 2026. It does not list the specific BCI device model, the actual number of participants enrolled, or any result data, and it states that the registration was not prospective.