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NOT YET RECRUITING
NCT07857109
NA

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

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-10-08

Completion Date

2028-04-30

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DEVICE

Low-Intensity Focused Ultrasound Stimulation

Participants receive active low-intensity focused ultrasound stimulation targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine.

DEVICE

Sham Low-Intensity Focused Ultrasound Stimulation

Participants undergo sham stimulation procedures with identical positioning, coupling, and treatment duration as the active stimulation group, but without effective ultrasound output.

Locations (1)

Chinese People's Liberation Army General Hospital, First Medical Center

Beijing, Beijing Municipality, China