BCIwiki (bciwiki.com) — Shandong Provincial Hospital plans to enroll 60 patients with acute ischemic stroke in a randomized, sham-controlled pilot study testing whether non-invasive, electroencephalography-based brain-computer interface (EEG-BCI) rehabilitation can be safely started in the first days after a stroke. The single-center, prospective trial, registered as NCT07585058, was first posted on ClinicalTrials.gov on May 13, 2026. It is not yet recruiting, with an estimated start in October 2026.
Eligible participants are adults aged 18 to 80 with unilateral upper-limb motor impairment on the dominant-hand side, a baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score of 10 to 50, and confirmed clinical stability 48 to 72 hours after stroke onset.
Participants will be randomized 1:1 to real EEG-BCI training or sham BCI training, each added to standard early rehabilitation. Both groups will train for 10 days, with 2 sessions per day of about 30 minutes each.
The primary outcome is the change in FMA-UE score from baseline to 30 days after randomization. Secondary outcomes include changes in FMA-UE, the Action Research Arm Test (ARAT), the National Institutes of Health Stroke Scale (NIHSS), the Modified Barthel Index (MBI) and the modified Rankin Scale (mRS). Safety outcomes include symptomatic and any intracranial hemorrhage, neurological deterioration, seizures, falls, cardiovascular events and training-related adverse events.
According to the investigators, the pilot is meant to provide preliminary evidence on feasibility, safety and potential efficacy and to inform the design of future multicenter randomized controlled trials. Primary completion is estimated for October 2027.