Chronic Migraine HeadacheNCT07857109
Low-Intensity Focused Ultrasound Targeting the Dorsolateral Prefrontal Cortex for Preventive Treatment of Chronic Migraine
A study testing Low-Intensity Focused Ultrasound Stimulation in people with Chronic Migraine Headache, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Chronic migraine is a disabling neurological disorder characterized by frequent headache attacks and significant impairment of quality of life. Low-intensity focused ultrasound (LIFUS) is a non-invasive neuromodulation technique that can precisely target deep brain regions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- Low-Intensity Focused Ultrasound Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 30 Apr 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with a history of migraine for at least 12 months before screening.
- Migraine onset at or before 50 years of age.
- During the 3 months before screening, participants have headache occurring on at least 15 days per month, with migraine features or migraine-specific treatment on at least 8 days per month.
- During the baseline prospective electronic headache diary period, participants record at least 8 migraine days and 15 to 27 headache days.
- Participants are able to comply with electronic headache diary recording requirements, with data recorded for at least 24 of the 28 days during the screening period.
- Age between 18 and 65 years at screening visit.
- Participants are willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- History of epilepsy, brain tumor, or traumatic brain injury.
- History of transcranial magnetic stimulation, transcranial direct current stimulation, or electroconvulsive therapy within the past 3 months.
- Presence of MRI-incompatible metallic implants, including but not limited to vascular stents, cardiac pacemakers, or ventriculoperitoneal shunts.
- Clinically significant comorbid chronic pain conditions, such as fibromyalgia, chronic low back pain, or complex regional pain syndrome.
- Diagnosis of acute or active temporomandibular disorder.
- History or diagnosis of other primary headache disorders, including chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or atypical migraine subtypes.
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- Use of opioid-containing analgesics for more than 4 days within 1 month before baseline or during baseline period.
- Use of any migraine preventive medication within 1 month prior to screening.
- Use of devices or surgical interventions for migraine treatment within 1 month before baseline, including transcranial magnetic stimulation, greater occipital nerve block, or invasive/non-invasive neuromodulation procedures.
- History of malignant tumors within the past 5 years, except adequately treated localized basal cell carcinoma or carcinoma in situ of the cervix.
- History of severe psychiatric disorders, including schizophrenia, other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, or post-traumatic stress disorder.
- Severe anxiety, depression, or manic symptoms according to predefined scale thresholds (SAS, SDS, and BRMS).
- Significant risk of self-harm or harm to others based on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment or investigator judgment.
- History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months before screening.
- Pregnancy or breastfeeding.
- Claustrophobia or inability to undergo MRI examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese People's Liberation Army General Hospital, First Medical Center
Beijing, Beijing Municipality
Zhao Dong, (+86) 18910685535, dong_zhaozhao@126.com
About this study
Official title: Efficacy and Safety of Low-Intensity Focused Ultrasound Targeting the Dorsolateral Prefrontal Cortex for Preventive Treatment of Chronic Migraine in Adults: A Randomized, Single-Blind, Sham-Controlled Trial
Chronic migraine is a disabling neurological disorder characterized by frequent headache attacks and significant impairment of quality of life. Low-intensity focused ultrasound (LIFUS) is a non-invasive neuromodulation technique that can precisely target deep brain regions. This study aims to evaluate the efficacy, safety, and tolerability of LIFUS targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine in adults.
This is a randomized, single-blind, sham-controlled clinical trial. Eligible participants with chronic migraine will be randomly assigned to receive either active LIFUS stimulation targeting the left DLPFC or sham stimulation. Participants will receive 10 stimulation sessions over 2 weeks and will be followed for 3 months after intervention.
The primary outcome is the change in monthly migraine days from baseline to 1 month after intervention. Secondary and exploratory outcomes include headache-related disability, quality of life, psychological assessments, electrophysiological measurements, neuroimaging changes, and safety outcomes.
- Conditions
- Chronic Migraine Headache
- Being tested
- Low-Intensity Focused Ultrasound Stimulation, Sham Low-Intensity Focused Ultrasound Stimulation
- Keywords
- Migraine, Chronic Migraine, Low-Intensity Focused Ultrasound, Focused Ultrasound Neuromodulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focused Ultrasound StimulationDevice
Participants receive active low-intensity focused ultrasound stimulation targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine.
Sham Low-Intensity Focused Ultrasound StimulationDevice
Participants undergo sham stimulation procedures with identical positioning, coupling, and treatment duration as the active stimulation group, but without effective ultrasound output.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC-LIFUS | Experimental | Not described Receives: Device: Low-Intensity Focused Ultrasound Stimulation |
| DLPFC-Sham | Sham comparator | Not described Receives: Device: Sham Low-Intensity Focused Ultrasound Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monthly Migraine Days
Change in monthly migraine days from baseline after intervention.
Measured: Baseline and 1 month after intervention
Secondary outcomes (14)
Change in Acute Headache Medication Days
Change in the number of days using acute headache medications from baseline to 1 month after intervention.
Measured: Baseline and 1 month after intervention
50% Responder Rate Based on Monthly Migraine Days
Proportion of participants achieving at least 50% reduction in monthly migraine days compared with baseline.
Measured: 1 month after intervention
75% Responder Rate Based on Monthly Migraine Days
Proportion of participants achieving at least 75% reduction in monthly migraine days compared with baseline.
Measured: 1 month after intervention
Change in Moderate/Severe Headache Days
Change in the number of moderate or severe headache days from baseline to 1 month after intervention.
Measured: Baseline and 1 month after intervention
Change in Visual Analog Scale (VAS) Score for Headache Intensity
Headache intensity is assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater headache intensity.
Measured: Immediately after each intervention session to 1 month after intervention
Change in Most Bothersome Migraine Symptom (MBS) Improvement Score
Participants identify their most bothersome migraine-associated symptom at baseline from nausea, vomiting, photophobia, or phonophobia. The same symptom is assessed during follow-up using a 7-point patient-reported improvement scale ranging from very much improved to very much worse.
Measured: Immediately after intervention and 1 month after intervention
Change in monthly Migraine Disability Assessment (mMIDAS) Score
The monthly Migraine Disability Assessment (mMIDAS) questionnaire assesses migraine-related disability during the previous month. Higher scores indicate greater migraine-related disability.
Measured: Baseline, immediately after intervention, and 1 month after intervention
Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Score
Measured: Baseline, immediately after intervention, and 1 month after intervention
Change in Headache Impact Test-6 (HIT-6) Score
The 6-item Headache Impact Test (HIT-6) assesses the impact of headache on daily functioning. Total scores range from 36 to 78, with higher scores indicating greater headache impact.
Measured: Baseline, immediately after intervention, and 1 month after intervention
Patient Global Impression of Change (PGI-C) Score
The Patient Global Impression of Change (PGI-C) is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher scores indicating less favorable perceived change.
Measured: Immediately after intervention and 1 month after intervention
Change in Generalized Anxiety Disorder 7-item (GAD-7) Score
The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: Baseline, immediately after intervention, and 1 month after intervention
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The Patient Health Questionnaire-9 (PHQ-9) assesses depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline, immediately after intervention, and 1 month after intervention
Incidence of Adverse Events
Number and proportion of participants who experience one or more adverse events during the study. All observed and spontaneously reported adverse events will be recorded regardless of their relationship to the study intervention; severity and relatedness will also be assessed.
Measured: From baseline through completion of the 3-month follow-up visit
Number of Participants with New Abnormal Findings on T2-Weighted MRI
Number of participants with new brain parenchymal signal abnormalities, hemorrhage, or edema identified on T2-weighted MRI within 24 hours after the final intervention compared with baseline.
Measured: Baseline and within 24 hours after the final intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Dong, MD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857109
- Sponsor's protocol ID
- S2026-344-01
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No