PRISM-CMNCT07891585

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

StatusRecruiting

PhaseNot applicable

SponsorTaichung Veterans General Hospital

Primary completionDec 31, 2030 (estimated)

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Record History

All 2 versions: 2 with changes below.

Notable Nov 6, 2026 Recruitment opened
- Study sites: 1 to 2
Oct 16, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Change From Baseline in Monthly Migraine Days (MMD) at Week 12

Timeframe: Baseline and Week 12 after treatment initiation

Secondary (13)

Change in Monthly Headache Days (MHD) From Baseline to Week 12

Change in Acute Medication Days (AMD) From Baseline to Week 12

Change in Headache Pain Intensity From Baseline to Week 12

Change in Headache Duration From Baseline to Week 12

Change in Migraine Disability Assessment (MIDAS) From Baseline to Week 12

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Change in Hospital Anxiety and Depression Scale (HADS) From Baseline to Week 12

Change in Beck Depression Inventory (BDI) From Baseline to Week 12

Change in Pittsburgh Sleep Quality Index (PSQI) Total Score From Baseline to Week 12

Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days at Week 12

Change in Regional Brain Volume Assessed by Structural MRI

Change in Resting-State Functional Connectivity Assessed by fMRI

Change in Brain Activation During Laser Acupuncture Assessed by fMRI

Change in White Matter Integrity Assessed by Diffusion Tensor Imaging

Arms and interventions

Chronic Migraine: Active Laser AcupunctureExperimental

Chronic Migraine: Sham Laser AcupunctureSham comparator

Healthy Volunteers: Active Laser AcupunctureExperimental

Devices: 810 nm laser acupuncture, Sham Laser Acupuncture

Sites

2 sites in 1 country

About this trial

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.

Trial details

Enrollment: 300 participants (estimated)
Started: Nov 1, 2026
Study completion: Dec 31, 2032 (estimated)
Eligibility: 20 and older, all sexes, healthy volunteers accepted
Design: Interventional, randomized, double blind, prevention
Oversight: Data monitoring committee
Conditions: Chronic Migraine Headache
Official title: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Functional Characteristics Associated With Laser Acupuncture in Chronic Migraine
First posted: Oct 23, 2026
Registry updated: Nov 12, 2026
Last verified: Oct 2026

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