BCIwiki (bciwiki.com) — A trial sponsored by Shanghai Yangzhi rehabilitation hospital and registered with the Chinese Clinical Trial Registry (ChiCTR) will evaluate whether rTMS-enhanced motor imagery brain-computer interface therapy improves upper limb dysfunction after stroke. The registration number is ChiCTR2600123173, with a registration date of April 22, 2026. The interventional, parallel-design study is prospectively registered and plans to enroll 213 participants, with first enrolment set for May 1, 2026; recruitment has not yet begun. Funding comes from the Shanghai Hospital Development Center.
The study has three parts. Part I assigns participants to motor imagery BCI therapy or conventional physical rehabilitation. Part III has three experimental arms: low-frequency rTMS, high-frequency rTMS, and high-frequency rTMS combined with low-frequency rTMS. The primary outcome is the Fugl-Meyer Assessment of the upper extremity (FMA-UE). Secondary outcomes include the Modified Barthel Index, the Wolf Motor Function Test, and accuracy of task completion.
Participants must have a stroke confirmed by head CT or MRI — ischemic or hemorrhagic — with residual unilateral upper limb motor dysfunction and a modified Fugl-Meyer upper extremity score of 60 points or lower. They must be 18 to 75 years old, at least 2 weeks past stroke onset, with muscle tone in the affected arm not yet at the spastic stage (modified Ashworth scale of 2 or lower), a Mini-Mental State Examination score of at least 24, and the ability to understand motor imagery tasks such as imagining grasping and extending and to complete 2 weeks of rehabilitation training. Part III additionally requires meeting diagnostic criteria for high risk of "BCI blindness" and a commitment to 3 months of follow-up, including functional assessment and neuroimaging.
Exclusion criteria include secondary paralysis from trauma, neurodegenerative disease such as Parkinson's disease or amyotrophic lateral sclerosis, or congenital neuromuscular disorders; severe cardiovascular, cerebrovascular, or psychiatric comorbidity; prior rehabilitation based on motor imagery BCI; skin damage, inflammation, or metal implants in the affected upper limb; a history of seizures or new-onset epilepsy after stroke without regular antiepileptic treatment; current use of antiepileptic or sedative drugs; contraindications to TMS such as intracranial metal implants; and ongoing neuromodulation such as tDCS.