Efficacy of Individualized Location-based Repetitive Transcranial Magnetic Stimulation in the Treatment of Migraine: a Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in the monthly average number of migraine days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Individualized location-based Repetitive Transcranial Magnetic Stimulation
Enhancing targeting accuracy through personalized target localization to improve the analgesic response rate of rTMS.
干预措施: Individualized location-based Repetitive Transcranial Magnetic Stimulation (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.
干预措施: Traditional location-based Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Change in the monthly average number of migraine days
时间窗: from baseline to 1 month after treatment completion.
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.
次要结局
- Mean Change From Baseline in Inflammatory Biomarker Levels.(Treatment completion (2 weeks) vs. baseline.)
- 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.)
- Mean Change From Baseline in the Patient Global Impression of Change(PGIC )(from baseline to 3 month after treatment completion.)
- Mean Change From Baseline in the HAMD-24 (Hamilton Depression Rating Scale, 24-item).(from baseline to 1.2.3 month after treatment completion.)
- Mean Change From Baseline in the HAMA-14 (Hamilton Anxiety Rating Scale, 14-item).(from baseline to 1.2.3 month after treatment completion.)
- Metabolomics (Tryptophan and Kynurenine)(Treatment completion (2 weeks) vs. baseline.)
- Mean Change From Baseline in Glutamate, Endocannabinoids and Related Lipids(Treatment completion (2 weeks) vs. baseline.)
- Mean Change From Baseline in Gut Microbiota Composition(Treatment completion (2 weeks) vs. baseline.)
- Changes in pain-related brain regions and connectivity in resting-state functional magnetic resonance imaging (rs-fMRI)(Treatment completion (2 weeks) vs. baseline.)