Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
研究概览
简要总结
This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.
详细描述
The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.
排除标准
- •headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.
研究组 & 干预措施
active tDCS over primary motor cortex
Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.
干预措施: TDCS (Device)
active tDCS over prefrontal cortex
Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.
干预措施: TDCS (Device)
sham tDCS over primary motor cortex
Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex.
干预措施: TDCS (Device)
结局指标
主要结局
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
时间窗: Baseline (week 1) and Endpoint (week 4)
次要结局
- Change in pain assessed on the Visual Analogue Scale (VAS)(Baseline (week 1) and Endpoint (week 4))
- Side Effects Questionnaire(From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month)
- Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)(Baseline (week 1) and and Endpoint (week 4))
研究者
Suellen Marinho Andrade
Professor
Federal University of Paraíba