Identification of Predictors of Treatment Response and Innovative Therapeutic Strategies Based on Non-Invasive Brain Stimulation in Patients With Chronic Migraine and Medication Overuse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of monthly days with moderate-to-severe headache
研究概览
简要总结
This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of non-invasive brain stimulation as an add-on treatment to standard detoxification therapy in patients with chronic migraine and medication overuse. The study also seeks to identify sensory and biochemical biomarkers predictive of treatment response.
详细描述
The main study is a randomized controlled trial enrolling patients with chronic migraine and medication overuse (MoH). Participants will undergo a standardized in-hospital detoxification protocol and will be randomly assigned to one of three parallel groups to receive either sham stimulation, active repetitive transcranial magnetic stimulation (rTMS) applied over the motor cortex face representation, or active rTMS applied over the motor cortex forearm representation. Stimulation will be delivered for five consecutive days.
Clinical, sensory (Quantitative Sensory Testing, QST), and biochemical measures (plasma glutamate, serotonin, and calcitonin gene-related peptide, CGRP) will be collected at baseline and during follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic migraine and medication overuse according to ICHD-3 criteria
- •Ability to provide written informed consent
排除标准
- •Major psychiatric disorders (e.g., major depressive disorder)
- •Changes in preventive migraine therapy within the last 3 months
- •Ongoing treatment with monoclonal antibodies for migraine prevention
- •Other significant neurological or systemic diseases
- •Pregnancy
- •Contraindications to transcranial magnetic stimulation (for main study participants)
研究组 & 干预措施
Active rTMS - Motor Cortex Face Representation
Participants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive high-frequency (10 Hz) active repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex corresponding to the face representation. Stimulation will be administered once daily for five consecutive days during hospitalization.
干预措施: Active rTMS Motor Cortex Face (Other)
Active rTMS - Motor Cortex Forearm Representation
Participants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive high-frequency (10 Hz) active repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex corresponding to the forearm representation. Stimulation will be administered once daily for five consecutive days during hospitalization.
干预措施: Active rTMS - Motor Cortex Forearm (Other)
Sham rTMS
Participants will undergo a standardized in-hospital detoxification protocol for medication overuse and will receive sham high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS). Sham stimulation will be delivered using identical stimulation parameters and session duration as active rTMS, with the coil positioned to avoid effective cortical stimulation. Treatment will be administered once daily for five consecutive days during hospitalization.
干预措施: Sham rTMS (Other)
结局指标
主要结局
Number of monthly days with moderate-to-severe headache
时间窗: 1 month post-treatment
Change in the mean number of monthly days with moderate-to-severe headache during the month following treatment
次要结局
- Change in plasma CGRP concentration(Up to 3 months post-treatment)
- Number of participants converting from chronic to episodic migraine(Up to 3 months post-treatment)
- Change in monthly number of acute headache medication intakes(Up to 3 months post-treatment)
- Acute headache medications(Up to 3 months post-treatment)
- Number of participants initiating preventive migraine therapy(Up to 3 months post-treatment)
- Change in Quantitative Sensory Testing (QST)(Up to 3 months post-treatment)
- Change in plasma glutamate concentration(Up to 3 months post-treatment)
- Change in plasma serotonin concentration(Up to 3 months post-treatment)