Low-Intensity Focused Ultrasound Targeting the Dorsolateral Prefrontal Cortex for Preventive Treatment of Chronic Migraine

NCT ID
NCT07857109
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Chinese PLA General Hospital
Conditions
Chronic Migraine Headache

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 36 participants (Estimated).

What is being studied

  • Device: Low-Intensity Focused Ultrasound Stimulation
  • Device: Sham Low-Intensity Focused Ultrasound Stimulation

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: China

  • Beijing Municipality, China: 1

Sample of listed locations

  • Chinese People's Liberation Army General Hospital, First Medical Center — Beijing, Beijing Municipality, China — Site recruitment status not specified in the registry data

Study details

Start date
October 8, 2026
Primary completion date
December 31, 2027
Completion date
April 30, 2028
First posted
October 5, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07857109
Registry last updated
October 5, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07857109 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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