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

NCT07891585 | Not Yet Recruiting DMC

• 1 other identifier: CF26593A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine Headache

Outcome Measures

Primary Outcomes (1)

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

  Monthly migraine days (MMD) will be calculated from daily headache diaries over a 28-day period. Change from baseline will be calculated as MMD at Week 12 minus baseline MMD. Negative values indicate a reduction in migraine frequency. The unit of measurement is days per 28 days.

  Baseline and Week 12 after treatment initiation

Secondary Outcomes (13)

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

  Baseline and monthly through Month 12

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

  Baseline and monthly through Month 12

• Change in Headache Pain Intensity From Baseline to Week 12

  Baseline and monthly through Month 12

• Change in Headache Duration From Baseline to Week 12

  Baseline and monthly through Month 12

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

  Baseline and monthly through Month 12

Study Arms (3)

Chronic Migraine: Active Laser Acupuncture

EXPERIMENTAL

Device: 810 nm laser acupuncture

Chronic Migraine: Sham Laser Acupuncture

SHAM COMPARATOR

Device: Sham Laser Acupuncture

Healthy Volunteers: Active Laser Acupuncture

EXPERIMENTAL

Device: 810 nm laser acupuncture

Interventions

810 nm laser acupuncture DEVICE

Participants will receive noninvasive laser acupuncture using an 810-nm near-infrared laser with an output power of 150 mW. Laser irradiation will be applied to 13 standardized acupoints: bilateral Fengchi (GB20), Shuaigu (GB8), Taiyang (EX-HN5), Zanzhu (BL2), Hegu (LI4), Taichong (LR3), and unilateral Yintang (EX-HN3). Each acupoint will be irradiated for 30 seconds, delivering 4.5 J of energy per point. Treatment will be administered twice weekly for four consecutive weeks, for a total of eight sessions. The same standardized treatment protocol will be used for participants with chronic migraine assigned to the active laser acupuncture group and healthy volunteers receiving active laser acupuncture.

Chronic Migraine: Active Laser Acupuncture; Healthy Volunteers: Active Laser Acupuncture

Sham Laser Acupuncture DEVICE

Participants assigned to the sham laser acupuncture group will undergo a procedure identical to active laser acupuncture, using the same laser device, standardized acupoints, treatment duration, and operating procedures, but without emission of therapeutic laser energy. The sham procedure will target the same 13 acupoints: bilateral Fengchi (GB20), Shuaigu (GB8), Taiyang (EX-HN5), Zanzhu (BL2), Hegu (LI4), Taichong (LR3), and unilateral Yintang (EX-HN3). Each acupoint will be treated for 30 seconds. Sham treatment will be administered twice weekly for four consecutive weeks, for a total of eight sessions. The procedure is designed to maintain participant blinding and serve as a placebo control for active laser acupuncture.

Chronic Migraine: Sham Laser Acupuncture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital Copy

Taichung, Taiwan

Location

Related Publications (4)

• Chang YC, Chen CM, Lay IS, Lee YC, Tu CH. The effects of laser acupuncture dosage at PC6 (Neiguan) on brain reactivity: a pilot resting-state fMRI study. Front Neurosci. 2023 Oct 12;17:1264217. doi: 10.3389/fnins.2023.1264217. eCollection 2023.

  PMID: 37901421 RESULT

• Quah-Smith I, Sachdev PS, Wen W, Chen X, Williams MA. The brain effects of laser acupuncture in healthy individuals: an FMRI investigation. PLoS One. 2010 Sep 7;5(9):e12619. doi: 10.1371/journal.pone.0012619.

  PMID: 20838644 RESULT

• Bowing G, Zhou J, Endres HG, Coeytaux RR, Diener HC, Molsberger AF. Differences in Chinese diagnoses for migraine and tension-type headache: an analysis of the German acupuncture trials (GERAC) for headache. Cephalalgia. 2010 Feb;30(2):224-32. doi: 10.1111/j.1468-2982.2009.01921.x.

  PMID: 19614709 RESULT

• Wu HY, Wang CS, Liu YC, Chung CC, Chen WL, Tsai CI, Hsu CY, Chou CH. Enhancing chronic migraine preventive therapy: low-level 810 nm laser acupuncture as an add-on treatment for patients with unsatisfactory pharmacological effect, a pilot single-blind randomized controlled trial. BMC Complement Med Ther. 2024 Aug 28;24(1):318. doi: 10.1186/s12906-024-04617-9.

  PMID: 39198866 RESULT

Central Study Contacts

HuanYun Wu, MD

CONTACT

886911603831; huanyun0230@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 11, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)