Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Migraine Disability Assessment - MIDAS
研究概览
简要总结
This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.
详细描述
The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS for 15 minutes. The tDCS will be applied for 10 days over 2 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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).
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
- •use of a cardiac pacemaker
研究组 & 干预措施
active tDCS
Active tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region
干预措施: tDCS (Other)
active tDCS with interval
Active tDCS for 15 minutes, interval of 20 minutes and more 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region
干预措施: tDCS (Other)
sham tDCS
Sham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region
干预措施: tDCS (Other)
结局指标
主要结局
Migraine Disability Assessment - MIDAS
时间窗: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.
次要结局
- Wechsler Intelligence Scale Numbers Test("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Headache Impact Test - HIT-6("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Nine Hole Peg Test("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Concentrated Attention Test("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Visual Attention Test (Attention Matrices)("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Montreal Cognitive Assessment("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Side Effects Questionnaire("every day for up to 2 weeks")
- Trail Making Test part B("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Hayling's Test Hayling's Test("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Salthouse Visual Patterns and Lyrics("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Wechsler Intelligence Scale Letters("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
- Paced Auditory Serial Addition Task("before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment")
研究者
Renata Emanuela Lyra de Brito Aranha
researcher
Federal University of Paraíba