BCIwiki (bciwiki.com) — Guangdong Provincial Hospital of Traditional Chinese Medicine has registered an interventional trial testing whether intermittent theta-burst stimulation (iTBS) over the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC) can improve the efficacy of motor imagery brain-computer interface (MI-BCI) training for post-stroke upper-limb impairment by modulating brain networks. The trial, ChiCTR2600124411, was registered with the Chinese Clinical Trial Registry on May 12, 2026, is carried by the WHO International Clinical Trials Registry Platform (ICTRP), and is not yet recruiting.
The parallel-design trial plans to enroll 81 participants in three groups of 27: a DLPFC group and an M1 group receiving iTBS plus BCI training, and a sham group receiving sham iTBS plus BCI training. Enrollment is listed as starting on June 1, 2026.
Eligible patients are 50 to 75 years old, have had a stroke diagnosed according to guidelines at least one month earlier, have unilateral upper-limb motor impairment at Brunnstrom stages I to IV, and score 10 to 30 on the Mini-Mental State Examination (MMSE). Exclusions include prior upper-limb fracture or deformity, unstable disease, serious organ dysfunction, cognitive impairment or aphasia, severe mental illness, antiepileptic drug use and implanted metal devices.
Primary outcomes are BCI decoding accuracy, the Fugl-Meyer Assessment and brain network topology; secondary outcomes are the Montreal Cognitive Assessment (MoCA) and activities of daily living. The registration does not give stimulation parameters, the length of the training course or the follow-up period, and no results have been reported.