BCIwiki (bciwiki.com) — A multicenter, randomized, controlled clinical study of a steady-state visual evoked potential (SSVEP) brain-computer interface driving functional electrical stimulation for post-stroke dysphagia has been registered with the Chinese Clinical Trial Registry (ChiCTR) under number ChiCTR2600125020, with a registration date of May 20, 2026. The primary sponsor is The First Affiliated Hospital of Xi'an Jiaotong University.
The trial is an interventional, parallel-design study that plans to enroll 90 participants, 45 in the trial group and 45 in the control group. Recruitment is listed for China, and participants must be 18 to 80 years old, of any gender. First enrollment is listed for June 1, 2026, and the registry page lists the recruitment status as not yet recruiting.
The two arms receive different interventions. The control group receives conventional neuromuscular electrical stimulation (NMES) for swallowing function combined with conventional swallowing rehabilitation therapy. The trial group receives SSVEP-based brain-computer interface-driven functional electrical stimulation for swallowing combined with conventional rehabilitation therapy. An SSVEP brain-computer interface infers intent from the brain's occipital response when a patient gazes at a target flickering at a specific frequency, and uses that signal to trigger stimulation.
Inclusion criteria require a first-ever hemorrhagic or ischemic stroke confirmed by CT or MRI, onset within 6 months, dysphagia with a Water Swallowing Test grade of 3, a Mini-Mental State Examination score above 24, no visual field defects or severe visual impairment, an intact skull, clear consciousness, stable vital signs and the ability to understand and follow study instructions, and voluntary participation with signed informed consent. Exclusions include severe cognitive impairment or aphasia, comorbid neurological disorders or head and neck tumors that cause dysphagia, a history of epilepsy, contraindications to electrical stimulation such as a cardiac pacemaker or intracranial metal implants, and current participation in other trials that could affect outcomes.
The primary outcome is the Standard Swallowing Assessment. Secondary outcomes include the Mini-Mental State Examination, the Repetitive Saliva Swallowing Test, the Functional Oral Intake Scale (FOIS), the Swallowing-Related Quality of Life Scale, the Penetration-Aspiration Scale, the 10-item Eating Assessment Tool, the Water Swallowing Test and the Dysphagia Outcome and Severity Scale (DOSS). Funding is listed as enterprise funding (Xiangyu Medical). The registry record was last updated on May 25, 2026. The registry page carries only bibliographic and design fields, with no results data; specific device models and actual enrollment numbers are not listed.