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

NCT07086274 | Not Yet Recruiting DMC

• 1 other identifier: [2025C]IIT. No. 013
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Keywords

Individualized location-based

Outcome Measures

Primary Outcomes (1)

• Change in the monthly average number of migraine days

  A migraine day: any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache: a migraine with or without aura, lasting for ≥30 minutes, and meeting at least 1 of the following criteria (a and/or b): a) ≥2 of the following: unilateral location, pulsating quality, moderate to severe pain intensity, aggravation by or causing avoidance of routine physical activity; b) ≥1 of the following: nausea and/or vomiting, photophobia, and phonophobia. If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms.

  from baseline to 1 month after treatment completion.

Secondary Outcomes (13)

• Change in the monthly average number of migraine days

  from baseline to 2.3 month after treatment completion.

• Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score

  Compared to baseline 3 months after treatment completion.

• Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ)

  from baseline to 1.2.3 month after treatment completion.

• Mean Change From Baseline in the Headache Impact Test-6 (HIT-6 )

  from baseline to 1.2.3 month after treatment completion.

• Mean Change From Baseline in the Pittsburgh Sleep Quality Index(PSQI )

  from baseline to 1.2.3 month after treatment completion.

Study Arms (2)

Individualized location-based Repetitive Transcranial Magnetic Stimulation

EXPERIMENTAL

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

Device: Individualized location-based Repetitive Transcranial Magnetic Stimulation

Traditional location-based Repetitive Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

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.

Device: Traditional location-based Repetitive Transcranial Magnetic Stimulation

Interventions

Individualized location-based Repetitive Transcranial Magnetic Stimulation DEVICE

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

Individualized location-based Repetitive Transcranial Magnetic Stimulation

Traditional location-based Repetitive Transcranial Magnetic Stimulation 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.

Traditional location-based Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• Red Cross Hospital, Hangzhou, China: collaborator
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yunze Li

CONTACT

86-13336136379; 1517055@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: July 25, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 25, 2027
• Study Completion (Estimated): July 25, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: mar-15-2025. jun-15-2027

Locations

CN (1)