Effect of Transcranial Direct Current Stimulation (tDCS) Optimized Protocol for the Treatment of Migraine
试验速览
- 阶段
- 2 期
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in headache diary variables
研究概览
简要总结
The aim of this study is to evaluate an optimized protocol of tDCS that normalize the lack of habituation and efficiency of inhibitory cortical circuits in migraine patients. For this purpose, migraineurs volunteers will undergo to optimized tDCS protocol or sham tDCS.
详细描述
A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with optimal protocol (defined in phase 1) and sham tDCS will be conducted to evaluated electrical cortical activity and pain control, number of migraine attacks and quality of life of migraine patients. Electrical cortical activity will be assessed through: (i) motor evoked potential (MEP); (ii) motor threshold (MT); (iii) short interval intracortical inhibition (SICI); (iv) intracortical facilitation (ICF); (v) phosphene threshold (PT) and (vi) visual evoked-potential (VEP-habituation). Clinical outcomes will be evaluated through: (i) headache diary; (ii) visual analog scale (VAS); (iii) Migrainde disability assessment (MIDAS); (iv) Headache Impact Test (HIT-6) and (v) World Health Organization quality of life assessment instrument (WHOQOL BREF).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of International Classification of Headache Disorders (ICHD-III)
- •Disease duration of at least 12 months
- •Without preventive medication for at least 6 months prior to initiation of treatment
排除标准
- •Pregnant women;
- •Pacemaker;
- •History of seizures;
- •Metallic implants in the head;
- •Patients with clinical evidence of brain injuries;
- •Chronic pain associated to others diseases;
- •Use of neuroleptic medications
研究组 & 干预措施
optimized protocol chosen
a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with optimal protocol (defined in phase 1) and sham tDCS will be conducted to evaluated electrical cortical activity and pain control, number of migraine attacks and quality of life of migraine patients. An interval of 48hs between sessions will be taken.
干预措施: tdcs (Device)
sham tDCS
a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with optimal protocol (defined in phase 1) and sham tDCS will be conducted to evaluated electrical cortical activity and pain control, number of migraine attacks and quality of life of migraine patients. An interval of 48hs between sessions will be taken.
干预措施: tdcs (Device)
结局指标
主要结局
Change in headache diary variables
时间窗: 3 followed months
it will be evaluated the number of migraine attacks, pain intensity, duration of each attack and number of painkillers intake. Patients will answer this diary during all experimental period (months).
次要结局
- Changes on inhibition and facilitation(through study completion, assessed up to 1 month (before and after each section))
- Changes from phosphene threshold(through study completion, assessed up to 1 month (before and after each section))
- Changes on Visual Evoked Potentials measures(at baseline, 1 month and 2 months, 3 months)
- Changes on HIT-6(at baseline, 1 month and 2 months, 3 months.)
- Changes on MIDAS(at baseline, 1 month and 2 months, 3 months.)
- Changes on VAS(at baseline, 1 month and 2 months, 3 months.)
- Changes on motor evoked potentials(through study completion, assessed up to 1 month (before and after each section))
研究者
Kátia Monte-Silva
Effect of Transcranial Direct Current Stimulation (tDCS) Optimized Protocol for the Treatment of Migraine
Universidade Federal de Pernambuco