BCIwiki (bciwiki.com) — Beijing Tiantan Hospital, Capital Medical University has registered a prospective, randomized, parallel-controlled trial of a non-invasive brain-computer interface robot based on mirror rehabilitation theory for upper-limb motor dysfunction after stroke, according to the Chinese Clinical Trial Registry. The registration number is ChiCTR2600123136 and the registration date is April 22, 2026. The interventional trial uses a parallel design and plans to enroll 40 patients, 20 in the experimental group and 20 in the control group. First enrollment is set for May 1, 2026, and recruitment has not yet begun.
The experimental group receives brain-computer interface integrated robotic mirror therapy; the control group receives conventional comprehensive rehabilitation therapy. Inclusion criteria require patients aged 30 to 80 with unilateral upper-limb motor dysfunction caused by primary ischemic or hemorrhagic stroke within 1 to 6 months before enrollment, and diffusion-weighted MRI at onset showing the lesion limited to the unilateral basal ganglia. Patients must also have a pre-stroke Modified Rankin Scale score of 0 to 2, an upper-extremity Fugl-Meyer score of 10 to 42, and a Montreal Cognitive Assessment score above 18. Exclusions include implanted electronic devices incompatible with MRI, prior stroke, and severe aphasia.
The primary outcome is the Fugl-Meyer Motor Function Assessment of the Upper Extremities. Secondary outcomes include the Montreal Cognitive Assessment, functional MRI, the Modified Barthel Index, electroencephalography, the Modified Ashworth Scale and the Wolf Motor Function Test. Funding comes from the Beijing Scholar Program. The registry record was last updated on April 27, 2026. The registry page carries only bibliographic and design fields, with no results data; the specific device model and actual enrollment numbers are not listed.