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临床试验/NCT07250464
NCT07250464尚未招募不适用

Investigation of Motor Evoked Potential and Cortical Silent Period in Migraine Patients

Istanbul Gelisim University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Cortical Silent Period (CSP) Duration

研究概览

简要总结

The primary objective of this study is to assess the level of inhibitory control in the motor cortex of migraine patients using objective and non-invasive methods. To this end, Motor Evoked Potential (MEP) and Cortical Silence Period (CSP) parameters obtained using Transcranial Magnetic Stimulation (TMS) will be measured and comparisons will be made between migraine patients and healthy controls. Since CSP duration is used specifically in the evaluation of GABA-B-mediated inhibitory mechanisms, it has the potential to directly measure the effect of migraine on cortical inhibition.

详细描述

Rationale and Background:

Migraine is a neurological disorder that significantly impairs individual quality of life and imposes substantial economic burdens on healthcare systems worldwide. Although its pathophysiology is not fully understood, recent research suggests that migraine is associated not only with vascular changes but also with alterations at neurological and cortical levels (Goadsby et al., 2017). Evidence increasingly indicates enhanced excitability and disrupted inhibitory mechanisms in central nervous system regions, including the motor cortex (Coppola et al., 2007).

Transcranial Magnetic Stimulation (TMS) is a non-invasive and reliable neurophysiological technique that stimulates the motor cortex and records muscle responses. Parameters obtained through TMS, such as Motor Evoked Potential (MEP) and Cortical Silent Period (CSP), are used to assess cortical excitability and inhibitory control, respectively (Chen et al., 1999). CSP is particularly useful for evaluating GABA-B-mediated inhibitory mechanisms. The hypothesis that migraine patients exhibit reduced cortical inhibition can be directly tested using CSP measurements.

Previous studies have reported shortened CSP durations and increased MEP amplitudes in migraine patients, suggesting cortical hyperexcitability (Brighina et al., 2002; Afra et al., 1998). However, these findings are inconsistent, and how they vary across migraine subtypes (with aura vs. without aura) remains unclear. Therefore, this study aims to characterize cortical physiological changes in migraine using objective and quantitative measures, filling gaps in the literature and contributing to clinical evaluations. Additionally, the relationship of these parameters with clinical features such as migraine type, duration, and attack frequency will be investigated to lay the groundwork for individualized neurophysiological profiling.

Primary and Secondary Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Participants and responsible investigators do not know group assignments. Only the technical staff performing TMS and EMG recordings are aware of group allocation.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-45 years.
  • Right-handed individuals.
  • Migraine patients: diagnosed according to International Headache Society (IHS) criteria.
  • Healthy controls: no history of migraine or other neurological disorders.
  • Able and willing to provide informed consent.

排除标准

  • History of epilepsy or other seizure disorders.
  • Presence of metal implants, pacemakers, or other contraindications to TMS.
  • Pregnancy or breastfeeding.
  • History of significant neurological or psychiatric disorders.
  • Use of medications that significantly alter cortical excitability (e.g., antiepileptics, benzodiazepines) in the last 2 weeks.
  • Any musculoskeletal condition preventing safe participation in EMG/TMS procedures.

结局指标

主要结局

Cortical Silent Period (CSP) Duration

时间窗: Single session measurement during TMS

CSP duration will be recorded from the first dorsal interosseous (FDI) muscle using surface EMG during TMS. CSP reflects GABA-B-mediated cortical inhibitory mechanisms, allowing direct assessment of cortical inhibition in migraine patients compared to healthy controls.

次要结局

  • Motor Evoked Potential (MEP) Amplitude(Single session measurement during TMS)

研究者

发起方
Istanbul Gelisim University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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