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

Zhejiang University

Status: Not yet enrolling

Conditions: Transcranial Magnetic Stimulation Repetitive; Migraine

Treatments: Device: Traditional location-based Repetitive Transcranial Magnetic Stimulation; Device: Individualized location-based Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07086274

[2025C]IIT. No. 013

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 2 patient groups

Individualized location-based Repetitive Transcranial Magnetic Stimulation

Experimental group

Description:

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

Treatment:

Device: Individualized location-based Repetitive Transcranial Magnetic Stimulation

Traditional location-based Repetitive Transcranial Magnetic Stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Traditional location-based Repetitive Transcranial Magnetic Stimulation