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2026-05-27 00:00 China Clinical Launch & Registration Translated from EN

Xuanwu Hospital Registers BCI Rehabilitation Trial Enrolling 58 Stroke Patients

Summary The randomized controlled trial plans to enroll 58 patients with upper limb motor dysfunction after stroke. The test group will receive feedback-based rehabilitation training through brain-computer interface interaction, while the control group will undergo traditional upper limb circular motion training. The primary outcome is the Fugl-Meyer Motor Assessment-Upper Extremity (FMA-UE), with secondary outcomes covering motor function, daily living activities, quality of life and neurophysiological measures including EEG, transcranial magnetic stimulation and fNIRS. The trial was prospectively registered, with first enrolment set for June 1, 2026, and recruitment has not yet started.
Why it matters Most BCI studies for post-stroke upper limb rehabilitation remain small feasibility efforts. This trial uses a randomized parallel controlled design, sets traditional circular motion training as the comparator, and adds EEG, transcranial magnetic stimulation and fNIRS to its secondary outcomes, meaning it will look not only at whether the hand moves but at what happens in the cortex and neural pathways. A sample of 58 is mid-sized for non-invasive BCI rehabilitation trials, and whether the results can link training effects to neural remodeling depends on enrolment progress after the June 2026 start.

BCIwiki (bciwiki.com) — Xuanwu Hospital, Capital Medical University has registered a randomized controlled trial at the Chinese Clinical Trial Registry to evaluate the efficacy of a brain-computer interface motor feedback training system for upper limb rehabilitation in stroke patients, under registration number ChiCTR2600125467, dated May 27, 2026. The interventional, parallel-design trial plans to enroll 58 patients, 29 in the test group and 29 in the control group, with first enrolment set for June 1, 2026. Recruitment has not yet started.

Eligible participants are stroke patients aged 35 to 75, of any gender, with a disease course of 2 weeks to 6 months and an FMA-UE score of no more than 47 on the affected side. The test group will receive feedback-based upper limb rehabilitation training through brain-computer interface interaction, while the control group will undergo traditional upper limb circular motion training. The primary outcome is the Fugl-Meyer Motor Assessment-Upper Extremity (FMA-UE). Secondary outcomes include the Wolf Motor Function Test, exercise capacity, motor evoked potentials, activities of daily living, quality of life, and neurophysiological assessments using EEG, transcranial magnetic stimulation and functional near-infrared spectroscopy.

The registration is prospective and self-funded, with the record last updated on June 1, 2026. The registration page does not list a specific BCI device model or actual enrolment numbers.

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