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.
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.
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.
Parallel
Low-Intensity Focused Ultrasound Stimulation
DeviceParticipants 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 Stimulation
DeviceParticipants undergo sham stimulation procedures with identical positioning, coupling, and treatment duration as the active stimulation group, but without effective ultrasound output.
Change in Monthly Migraine Days
Change in monthly migraine days from baseline after intervention.
Change in Acute Headache Medication Days
Change in the number of days using acute headache medications from baseline to 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.
75% Responder Rate Based on Monthly Migraine Days
Proportion of participants achieving at least 75% reduction in monthly migraine days compared with baseline.
Change in Moderate/Severe Headache Days
Change in the number of moderate or severe headache days from baseline to 1 month after intervention.
Long-term Change in Monthly Acute Headache Medication Days
Change in the number of days using acute headache medications compared with baseline during extended follow-up
Long-term Migraine Responder Rate (≥50%)
Proportion of participants achieving at least 50% reduction in monthly migraine days compared with baseline during extended follow-up.
Long-term Change in Moderate/Severe Headache Days
Change in monthly moderate/severe headache days compared with baseline during extended follow-up.
Long-term Change in Migraine Disability (mMIDAS)
Change in monthly Migraine Disability Assessment (mMIDAS) score compared with baseline during extended follow-up.
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