Chronic Migraine HeadachePRISM-CMNCT07891585
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
A study testing 810 nm laser acupuncture in people with Chronic Migraine Headache, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- 810 nm laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2026to 31 Dec 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taichung Veterans General Hospital Copy
Taichung
HuanYun Wu, 8860911603831, huanyun0230@gmail.com
About this study
Official title: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Functional Characteristics Associated With Laser Acupuncture in Chronic Migraine
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.
Read more
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
- Being tested
- 810 nm laser acupuncture, Sham Laser Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
810 nm laser acupunctureDevice
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.
Sham Laser AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Migraine: Active Laser Acupuncture | Experimental | Not described Receives: Device: 810 nm laser acupuncture |
| Chronic Migraine: Sham Laser Acupuncture | Sham comparator | Not described Receives: Device: Sham Laser Acupuncture |
| Healthy Volunteers: Active Laser Acupuncture | Experimental | Not described Receives: Device: 810 nm laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12 after treatment initiation
Secondary outcomes (13)
Change in Monthly Headache Days (MHD) From Baseline to Week 12
Monthly headache days (MHD) will be calculated from daily headache diaries as the number of days with headache during a 28-day period. Change from baseline will be calculated as the Week 12 value minus the baseline value. Negative values indicate fewer headache days. The unit of measurement is days per 28 days.
Measured: Baseline and monthly through Month 12
Change in Acute Medication Days (AMD) From Baseline to Week 12
Acute medication days (AMD) will be defined as the number of days on which participants use acute medication for headache or migraine during a 28-day period, as recorded in daily headache diaries. Change from baseline will be calculated as the Week 12 value minus the baseline value. Negative values indicate reduced acute medication use. The unit of measurement is days per 28 days.
Measured: Baseline and monthly through Month 12
Change in Headache Pain Intensity From Baseline to Week 12
Headache pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater headache intensity. Change from baseline will be calculated as the Week 12 score minus the baseline score. Negative values indicate improvement.
Measured: Baseline and monthly through Month 12
Change in Headache Duration From Baseline to Week 12
Headache duration will be recorded in daily headache diaries and expressed as the average duration of headache episodes in hours. Change from baseline will be calculated as the Week 12 value minus the baseline value. Negative values indicate shorter headache duration.
Measured: Baseline and monthly through Month 12
Change in Migraine Disability Assessment (MIDAS) From Baseline to Week 12
Migraine-related disability will be assessed using the Migraine Disability Assessment (MIDAS). The total score is calculated by summing the number of days of missed or reduced activities across five items during the preceding three months. Higher scores indicate greater migraine-related disability.
Measured: Baseline and monthly through Month 12
Change in Hospital Anxiety and Depression Scale (HADS) From Baseline to Week 12
Emotional distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale comprises 14 items divided into anxiety and depression subscales, each ranging from 0 to 21. The total score ranges from 0 to 42, with higher scores indicating greater emotional distress.
Measured: Baseline and monthly through Month 12
Change in Beck Depression Inventory (BDI) From Baseline to Week 12
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline and monthly through Month 12
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score From Baseline to Week 12
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score is calculated by summing seven component scores, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be calculated as the Week 12 score minus the baseline score. Negative values indicate improvement.
Measured: Baseline and monthly through Month 12
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days at Week 12
A migraine responder will be defined as a participant achieving at least a 50% reduction in monthly migraine days (MMD) at Week 12 compared with baseline. The outcome will be reported as the percentage of participants meeting this criterion in each treatment group. Higher percentages indicate a greater proportion of treatment responders.
Measured: Baseline and monthly through Month 12
Change in Regional Brain Volume Assessed by Structural MRI
Structural magnetic resonance imaging (MRI) will be used to assess longitudinal changes in regional brain volume following laser acupuncture treatment. Brain volume will be measured in cubic millimeters (mm³). Changes will be evaluated from baseline to Months 3 and 6. Higher or lower values do not necessarily indicate better or worse clinical outcomes.
Measured: Baseline, Month 3, and Month 6
Change in Resting-State Functional Connectivity Assessed by fMRI
Resting-state functional magnetic resonance imaging (fMRI) will be used to assess longitudinal changes in brain functional connectivity following laser acupuncture treatment. Functional connectivity will be quantified using Fisher's z-transformed correlation coefficients. Changes will be evaluated from baseline to Months 3 and 6. Higher or lower values indicate differences in functional connectivity and do not necessarily represent better or worse clinical outcomes.
Measured: Baseline, Month 3, and Month 6
Change in Brain Activation During Laser Acupuncture Assessed by fMRI
Task-based functional magnetic resonance imaging (fMRI) will be used to evaluate brain activation responses during laser acupuncture stimulation. Brain activation will be quantified using blood oxygen level-dependent (BOLD) signal changes, expressed as percentage signal change relative to a reference condition. Longitudinal changes will be evaluated from baseline to Months 3 and 6. Higher or lower values do not necessarily indicate better or worse clinical outcomes.
Measured: Baseline, Month 3, and Month 6
Change in White Matter Integrity Assessed by Diffusion Tensor Imaging
Diffusion tensor imaging (DTI) will be used to assess longitudinal changes in white matter microstructure following laser acupuncture treatment. White matter integrity will be evaluated using fractional anisotropy (FA), a unitless measure ranging from 0 to 1. Changes will be evaluated from baseline to Months 3 and 6. Higher FA values reflect greater directional organization of water diffusion and do not necessarily indicate better clinical outcomes.
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huan-Yun Wu, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891585
- Sponsor's protocol ID
- CF26593A
- Acronym
- PRISM-CM
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37901421Quah-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.
PubMed 20838644Bowing 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.
PubMed 19614709Wu 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.
PubMed 39198866