Clinical Trial

Individualized Location-based rTMS for Migraine Treatment: A Multicenter Clinical Study

Study acronym: individua rTMS
Not Yet Recruiting
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Summary
For migraine patients experiencing at least four attack days per month and undergoing transcranial magnetic stimulation (TMS) treatment, a randomized, double-blind controlled trial is conducted, dividing participants into a traditional targeting group and an individualized targeting group. Patients in both groups are followed up before treatment and at 1, 2, and 3 months post-treatment, evaluating the following parameters: migraine diaries, the number of migraine days, rescue medication usage, headache intensity, the number of moderate-to-severe migraine days, and the proportion of patients achieving a ≥50% reduction in migraine days. Further assessments include changes in the Migraine Disability Assessment (MIDAS), Headache Impact Test-6 (HIT-6), Migraine-Specific Quality of Life Questionnaire (MSQ), Pittsburgh Sleep Quality Index (PSQI), Patient Global Impression of Change (PGIC), 24-item Hamilton Depression Scale (HAMD-24), and 14-item Hamilton Anxiety Scale (HAMA-14). Biomarker and metabolic analyses include tryptophan and kynurenine metabolism, calcitonin gene-related peptide (CGRP), pituitary adenylate cyclase-activating polypeptide (PACAP), vasoactive intestinal peptide (VIP), neuropeptide Y (NPY), substance P, endothelin-1, inflammatory cytokines (IL-1β, IL-6, TNF-α, TGF-β1), glutamate, endocannabinoids and related lipids, as well as gut microbiota composition. Additionally, changes in resting-state functional magnetic resonance imaging (rs-fMRI) before and after treatment are analyzed. This study aims to compare the efficacy of TMS treatment under different targeting strategies in migraine patients, providing theoretical support for clinical applications.
Trial Details
NCT Number NCT07086274
Lead Sponsor First Affiliated Hospital of Zhejiang University
Collaborators: The Affiliated Hospital of Hangzhou Normal University, Red Cross Hospital, Hangzhou, China, The Third Affiliated hospital of Zhejiang Chinese Medical University
Conditions Migraine, Transcranial Magnetic Stimulation Repetitive
Enrollment 152 participants
Start Date 2025-07-25
Primary Completion 2027-07-25 (estimated)
Study Completion 2027-07-25 (estimated)
Updated on ClinicalTrials.gov 2025-07-25