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2026-06-03 00:00 China Clinical Launch & Registration Translated from EN

Northwestern Polytechnical University Registers BCI Stroke Rehabilitation Trial With 4 Arms

Summary A newly registered trial tests a brain-computer interface in post-stroke rehabilitation across 4 parallel arms: full cross-domain (emotion-cognition-motor) adaptive training, integrated cognitive and motor task training, single-dimension motor training, and conventional rehabilitation. Each arm plans 22 participants, 88 in total. It enrolls patients aged 30 to 80 with a first cerebral infarction or hemorrhage 3 months to 1 year earlier, unilateral hemiplegia, and upper-limb Brunnstrom stage II to IV. The primary outcome is a motor function score; secondary outcomes include EEG motor imagery event-related synchronization/desynchronization, prefrontal theta/alpha power ratio, and EEG-fNIRS coupling.
Why it matters This trial folds emotion regulation and cognitive tasks into a BCI rehabilitation protocol and compares it against motor-only and conventional rehabilitation, asking whether training more domains beats training the hand alone. With 22 participants per arm and 88 in total, the primary outcome is only a motor function score while EEG measures sit in the secondary outcomes, so it must first show functional improvement before any mechanism claim. First enrolment is set for June 10, 2026, and the trial has not yet started recruiting.

BCIwiki (bciwiki.com) — China's Chinese Clinical Trial Registry has listed a trial of a brain-computer interface-driven emotion regulation and cognitive-motor integration rehabilitation paradigm for post-stroke recovery, registration number ChiCTR2600126111, registered on June 3, 2026, with recruitment status not yet recruiting. The sponsor is Northwestern Polytechnical University, and first enrolment is set for June 10, 2026.

The trial is an interventional, parallel-design study with 4 arms, each planning 22 participants, 88 in total. The arms are full cross-domain (emotion-cognition-motor) adaptive training, integrated cognitive and motor task rehabilitation training, single-dimension motor rehabilitation training, and conventional rehabilitation training. The condition is stroke, and the recruiting country is China.

Inclusion criteria require a stroke diagnosis confirmed by cranial CT or MRI as a first cerebral infarction or cerebral hemorrhage; a disease course of 3 months to 1 year (late subacute to recovery phase); age 30 to 80; unilateral hemiplegia with the affected upper limb at Brunnstrom stage II to IV or CMSA upper-limb stage 2 to 3; a Montreal Cognitive Assessment (MoCA) score of at least 26 or Mini-Mental State Examination (MMSE) score of at least 24; and voluntary informed consent from the patient or legal guardian. Exclusions include altered consciousness, severe aphasia, visual or auditory impairment, unilateral neglect, agnosia or apraxia that prevents task completion, severe cardiovascular disease, a history of neurological conditions such as dementia or Parkinson's disease, psychiatric disorders, brainstem or cerebellar lesions, intracranial tumors, and arteriovenous malformations.

The primary outcome is a motor function score. Secondary outcomes include recovery stage of gross motor function of the hemiplegic upper extremity and hand, cognition, anxiety, depression, EEG-based motor imagery event-related synchronization/desynchronization, an EEG-based cognitive load index (prefrontal theta/alpha power ratio), an EEG frontal alpha asymmetry index of emotional/motivational tendency, activities of daily living, brain region activation intensity, a muscle synergy index, and EEG-fNIRS coupling. Funding is self-selected topic with self-raised funds. The registration record was last updated on June 8, 2026.

Compiled by BCIwiki from public sources

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