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临床试验/NCT04031781
NCT04031781已完成不适用

The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis

Ain Shams University0 个研究点目标入组 33 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
主要终点
Migraine attack frequency

研究概览

简要总结

The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.

A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition
  • With a headache frequency of 4-14 per month for the last six months
  • Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications.

排除标准

  • Patients with past family history of seizures
  • Other chronic pain disorders
  • Severe depression (Beck Depression Inventory of 30 or more)
  • Other significant neurologic or psychiatric diagnosis including substance misuse
  • Metal implants in the head
  • Pregnant or breastfeeding ladies
  • Prior experience with TMS

研究组 & 干预措施

Receiving repetitive transcranial magnetic stimulation (rTMS)

Active Comparator

This group received 5 rTMS sessions, delivered over one week over the left dorsolateral prefrontal cortex (LDLPFC ) at 5-Hz frequency and 100% motor threshold intensity.

干预措施: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold (Device)

Group receiving placebo rTMS

Placebo Comparator

This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output

干预措施: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold (Device)

结局指标

主要结局

Migraine attack frequency

时间窗: 2 months

The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.

次要结局

  • Functional disability(2 months)
  • Use of abortive pills(2 months)
  • Migraine days(2 months)
  • Migraine attack severity(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer Emara

Assistant professor of neurology

Ain Shams University

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