BCIwiki (bciwiki.com) — A multicenter clinical study has been registered with the Chinese Clinical Trial Registry (ChiCTR) to evaluate the effectiveness and safety of a non-invasive brain-computer interface combined with MRI-guided multichannel temporal interference stimulation (MRgTIS) in refractory migraine. The registration number is ChiCTR2600123821, dated April 30, 2026, and the primary sponsor is The First Affiliated Hospital of Bengbu Medical University. The first enrollment date is listed as May 1, 2026, and recruitment status is not yet recruiting.
The trial is an interventional, parallel-design study that plans to enroll 78 participants, 39 in a real-stimulation group and 39 in a sham-stimulation group. Eligible patients are right-handed, aged 18 to 65, of any sex, with chronic migraine or episodic refractory migraine diagnosed under the International Classification of Headache Disorders (ICHD-3). The real-stimulation group receives MRI-guided multichannel time-domain interference stimulation; the sham group receives a corresponding sham procedure. The primary outcome is headache frequency. Secondary outcomes include headache impact measured with the Migraine Disability Assessment Scale (MIDAS), pain severity rated on a Visual Analogue Scale (VAS), and emotional state.
Funding comes from Bengbu Medical University's "Bidding for Research Projects" Scientific Research Breakthrough Initiative, according to the registration. Exclusion criteria cover MRI contraindications such as pacemakers, deep brain stimulators, aneurysm clips and some metal implants; contraindications to temporal interference stimulation, including intracranial implants, head metal that cannot be safely removed, and use of barbiturates, benzodiazepines or certain anticonvulsants; impaired liver or kidney function or major neurological and psychiatric disease; pregnancy or breastfeeding; participation in another clinical trial within the past 3 months; and recent drug or alcohol abuse.
The registration page contains only bibliographic and design fields, with no results data and no device model or actual enrollment figure. The study is prospective and based in China. MRI-guided temporal interference stimulation has so far been explored mainly in animal and early human studies; whether this multicenter, sham-controlled trial shows a benefit in refractory migraine will depend on the primary endpoint once it is read out.