NCT07086274Not yet recruiting
Individualized Location-based rTMS for Migraine Treatment: A Multicenter Clinical Study
Efficacy of Individualized Location-based Repetitive Transcranial Magnetic Stimulation in the Treatment of Migraine: a Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 25 Jul 2027
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Migraine
- NCT number
- NCT07086274
What you commit to
- Study type: Interventional
- Planned participants: 152
- From 25 Jul 2025 to the primary completion date, 25 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications to TMS (e.g., metal implants, pacemakers).
Other illness
- History of migraine prophylactic drug adjustment during the screening and treatment period.
Other
- Severe anxiety or depression (HAMD score \>35, HAMA score \>29).
- Aphasia or cognitive dysfunction (MMSE score ≤23).
- Pregnancy or lactation.
- Clinicians assess severe comorbidities that are not treatable.
Who the study is looking for
- Aged between 18 and 65 years; both men and women.
- Diagnosis of migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-III), with first onset before age 50 and a history of migraine for more than 1 year.
- Migraine frequency of ≥4 days per month during both the 3 months prior to the screening period and the screening period itself.
- Informed consent documents are signed, and subjects are cooperative with the evaluation and rTMS treatment, having been informed of known and potential risks and available alternative treatments.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.