Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function

The PRISM-CM study will test whether 810-nanometer laser acupuncture reduces migraine days and related symptoms in adults with chronic migraine. Laser acupuncture uses low-level laser light at acupuncture points without inserting needles. The study will also assess safety and explore whether clinical features, traditional Chinese medicine syndrome patterns, and brain function are associated with differences in treatment response. This study will enroll 135 participants at Taichung Veterans General Hospital: 90 patients with chronic migraine and 45 healthy volunteers. After keeping a headache diary for 4 weeks before treatment, patients will be assigned by chance to active laser acupuncture or sham laser acupuncture, with 45 patients in each group. Sham treatment uses the same acupuncture points and procedures but does not deliver therapeutic laser energy. Healthy volunteers will not be randomized and will receive active laser acupuncture as a comparison group. All three groups will receive 8 sessions over 4 weeks. Patients with chronic migraine, outcome assessors, and staff analyzing brain images and study data will not be told which treatment was assigned. The practitioners providing treatment will know the assignment. All participants will complete questionnaires and standardized traditional Chinese medicine assessments before treatment and monthly through 12 months after treatment begins. The traditional Chinese medicine assessments use symptom questions, tongue images, and pulse examinations to identify patterns of signs and symptoms, called syndrome patterns. Patients with chronic migraine will also continue recording headache diaries. The main outcome is the change in the number of migraine days per month from before treatment to week 12. Other outcomes include headache severity and duration, days using medicines to treat headache attacks, headache-related limitations, anxiety and depressive symptoms, sleep, sensitivity to light and sound, quality of life, and adverse events. All three groups will undergo brain magnetic resonance imaging (MRI) before treatment and at week 12 after treatment begins. An additional MRI at week 4 is optional and depends on participant willingness and study resources. The scans will examine brain structure, connections between brain regions, and brain activity at rest and during laser stimulation of acupuncture points. Researchers will compare active and sham treatment in patients with chronic migraine. Healthy volunteers will provide a reference for brain imaging and questionnaire findings but will not be included in the main analysis of migraine treatment effects. Exploratory analyses will examine whether clinical features and traditional Chinese medicine syndrome patterns before treatment are associated with greater or smaller treatment benefits. The study will also compare patients with marked improvement and those with little or no improvement, and examine how brain changes relate to clinical response and traditional Chinese medicine syndrome patterns.

Inclusion Criteria: General Criteria: Adults aged 20 years or older. Able to understand the study procedures and provide written informed consent. Willing to participate in the scheduled treatments, clinical assessments, and follow-up visits. Patients with Chronic Migraine: Diagnosis of chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), confirmed by a neurologist. Unsatisfactory response to current pharmacological treatment or a need for adjunctive nonpharmacological treatment. Able to complete a 4-week baseline headache diary before randomization. Healthy Volunteers: No current or previous history of migraine, other recurrent primary headache disorders, or chronic pain conditions. Willing to receive the standardized 810-nm laser acupuncture treatment and undergo scheduled clinical and neuroimaging assessments. Exclusion Criteria: General Criteria: Inability to provide informed consent or comply with study procedures and follow-up assessments. Significant cognitive impairment or other conditions that may compromise participant safety or study compliance. Patients with Chronic Migraine: Active psychotic symptoms or unstable major psychiatric disorders. Other conditions that may significantly interfere with informed consent, study adherence, or MRI safety. Healthy Volunteers: Major or active neurological or psychiatric disorders that may substantially affect central nervous system function or MRI findings. Regular use of psychiatric medications.