BCIwiki (bciwiki.com) — A trial in burning mouth syndrome has been registered with the Chinese Clinical Trial Registry (ChiCTR) under number ChiCTR2600124987, with a registration date of May 20, 2026. The interventional, parallel-group study is sponsored by Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, and funded by the hospital's Brain-Computer Interface Special Research Program. It plans to enroll 38 participants, 19 in an active stimulation group and 19 in a sham group, with first enrollment set for June 1, 2026; recruitment has not yet started.
The intervention is transcranial direct current stimulation, with the anode placed over the left dorsolateral prefrontal cortex and the cathode over the right frontal pole. Stimulation parameters are 2 mA, 20 minutes per session, twice daily at a 2-hour interval, 2 to 3 days per week for 2 consecutive weeks, for 10 sessions in total. The sham group receives a "short onset plus current decay" protocol as the placebo control. The study also collects resting-state brain function, gray matter volume and cortical thickness, along with unstimulated salivary flow rate and salivary molecules.
The primary outcome is the level of oral mucosal pain. Secondary outcomes include the sensory and affective aspects of pain, the state of central sensitization, symptoms of generalized anxiety, depressive symptoms, oral health-related quality of life, sleep quality, Clinical Global Impression and Patient Global Impression. Inclusion requires a diagnosis of burning mouth syndrome under the International Classification of Headaches, Third Edition (ICHD-3), age 18 to 75 with no gender restriction, pain lasting at least 3 months, and a Visual Analogue Score above 3.
Exclusion criteria cover detectable organic lesions of the oral mucosa, a history of orofacial neuralgia, head and neck radiotherapy, diabetes and autoimmune disease, primary psychiatric disorders, other chronic pain conditions, and contraindications to transcranial direct current stimulation or MRI. The registration record was last updated on May 25, 2026. The registry page carries only bibliographic and design fields and does not list the specific stimulation device model or the actual number of participants enrolled.