An interventional study of 810 nm laser acupuncture and Sham Laser Acupuncture in Chronic Migraine Headache, sponsored by Taichung Veterans General Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Taichung Veterans General Hospital · Not applicable, Interventional, and Prevention
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.
Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Device: 810 nm laser acupuncture
Device: Sham Laser Acupuncture
Device: 810 nm laser acupuncture
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.
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.
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.
Time frame: Baseline and Week 12 after treatment initiation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 3, and Month 6
Plan to share: Yes
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taichung Veterans General Hospital →