Optimizing the Effect of Transcranial Direct Current Stimulation (tDCS) 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
- Changes on VAS
研究概览
简要总结
The aim of this study is to establish an optimized protocol of tDCS that normalize the lack of habituation and efficiency of inhibitory cortical circuits in migraine patients and determine tDCS polarity and the best cortical areas to stimulate which could normalize the lack of habituation and efficiency of inhibitory cortical circuits. For this, migraineurs volunteers will undergo to some tDCS protocols or sham tDCS.
详细描述
A crossover trial to establish an optimized tDCS protocol will be accomplished. Anodal and cathodal tDCS will be applied over the primary motor cortex (C3 - active and contralateral supra-orbital region - reference) and visual cortex (Oz - active and Cz - reference). Dual tDCS (anodal and cathodal - optimized protocol) will be applied on C3 - active and Oz - active.
Electrical cortical activity will be assessed on 14 migraineurs through: (i) MEP; (ii) MT; (iii) SICI; (iv) ICF; (v) PT and (vi) visual evoked-potential (VEP-habituation). An interval of 48hs between sessions will be taken. The order of the sessions will be randomized and counterbalanced among volunteers by site www.randomization.com.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Ages: 18-55 years
- •Gender: Both
- •Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of 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
anodal tDCS on M1
anodal tDCS on left primary motor cortex
干预措施: anodal tDCS on M1 (Procedure)
cathodal tDCS on M1
cathodal tDCS on left primary motor cortex
干预措施: cathodal tDCS on M1 (Procedure)
anodal tDCS on V1
anodal tDCS on visual cortex
干预措施: anodal tDCS on V1 (Procedure)
cathodal tDCS on V1
cathodal tDCS on visual cortex
干预措施: cathodal tDCS on V1 (Procedure)
anodal tDCS on M1 and cathodal on V1
dual tDCS - anodal tDCS on left primary motor cortex and cathodal on visual cortex
干预措施: anodal tDCS on M1 and cathodal on V1 (Procedure)
cathodal tDCS on M1 and anodal on V1
dual tDCS - cathodal tDCS on left primary motor cortex and anodal on visual cortex
干预措施: cathodal tDCS on M1 and anodal on V1 (Procedure)
sham tDCS
sham tDCS
干预措施: sham tDCS (Procedure)
结局指标
主要结局
Changes on VAS
时间窗: through study completion, assessed up to 3 weeks (before and after each section)
this scale will be used to measure the patients' pain intensity. VAS is an important instrument to verify, reliably, the patient's evolution during treatment. This scale will be used at beginning and end of each period (observation and treatment), before and after each tDCS session. For the VAS use, pain intensity will be asked to the patient. 0 cm means total pain absence and 10 cm is the level of maximum pain bearable by the patient.
次要结局
- Changes on Visual Evoked Potentials measures(through study completion, assessed up to 3 weeks (before and after each section))
- Changes from phosphene threshold(through study completion, assessed up to 3 weeks (before and after each section))
- Changes on motor evoked potentials(through study completion, assessed up to 3 weeks (before and after each section))
- Changes on intracortical inhibition(through study completion, assessed up to 3 weeks (before and after each section))
- Changes on intracortical facilitation(through study completion, assessed up to 3 weeks (before and after each section))
研究者
Kátia Monte-Silva
Principal Investigator
Universidade Federal de Pernambuco