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

NCT ID: NCT07086274

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2027-07-25

Brief 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.

Conditions

Migraine; Transcranial Magnetic Stimulation Repetitive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Individualized location-based Repetitive Transcranial Magnetic Stimulation

Enhancing targeting accuracy through personalized target localization to improve the analgesic response rate of rTMS.

Group Type: EXPERIMENTAL

Individualized location-based Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Enhancing targeting accuracy through personalized target localization to improve the analgesic response rate of rTMS.

Traditional location-based Repetitive Transcranial Magnetic Stimulation

Recent studies have shown that the dorsolateral prefrontal cortex (DLPFC) plays an inhibitory role in the human pain pathway. High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the left DLPFC has been found to improve chronic migraine.

Group Type: ACTIVE_COMPARATOR

Traditional location-based Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Recent studies have shown that the dorsolateral prefrontal cortex (DLPFC) plays an inhibitory role in the human pain pathway. High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the left DLPFC has been found to improve chronic migraine.

Interventions

Individualized location-based Repetitive Transcranial Magnetic Stimulation

Enhancing targeting accuracy through personalized target localization to improve the analgesic response rate of rTMS.

Intervention Type: DEVICE

Traditional location-based Repetitive Transcranial Magnetic Stimulation

Recent studies have shown that the dorsolateral prefrontal cortex (DLPFC) plays an inhibitory role in the human pain pathway. High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the left DLPFC has been found to improve chronic migraine.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with contraindications to TMS (e.g., metal implants, pacemakers).
• Severe anxiety or depression (HAMD score >35, HAMA score >29).
• History of migraine prophylactic drug adjustment during the screening and treatment period.
• Aphasia or cognitive dysfunction (MMSE score ≤23).
• Pregnancy or lactation.
• Clinicians assess severe comorbidities that are not treatable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role: collaborator

Red Cross Hospital, Hangzhou, China

OTHER

Sponsor Role: collaborator

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Yunze Li

Role: CONTACT

1517055@zju.edu.cn

86-13336136379

Facility Contacts

Li

Role: primary

zdyymzb@126.com

+ 86（ 571） 8723 6309

Other Identifiers

[2025C]IIT. No. 013

Identifier Type: -

Identifier Source: org_study_id