Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Migraine disabIlity assessment questionnaire - MIDAS
研究概览
简要总结
This study is a group controlled clinical trial. ParallelParallel study, patients aged 25-50 years, with Migraine Chronicle. Twelve sessions will be held during four mindfulness practice with four recordings (one per week). As a brainwave biomarker, the Muse, a Electroencephalogram (EEG). The investigators will use the MIDAS questionnaire, the HIT-6 Questionnaire and the FFMQ-BR. Based on the use of tDCS in patients with chronic pain, and in benefits of Mindfulness practice in these patients, the objective is to evaluate if the mindfulness-associated TCCA provides satisfactory results in the painful prophylaxis of patients with chronic migraine.
详细描述
Background: Chronic Migraine is a difficult to diagnose disease whose symptoms affect the quality of life of those affected. This study is a group controlled clinical trial. ParallelParallel study, patients aged 25-50 years, with Migraine Chronicle Methods / Design: Will be held at the Aging Studies Laboratory and Neuroscience of the Federal University of Paraíba. Twelve sessions will be held during four mindfulness practice with four recordings (one per week). As a brainwave biomarker, the Muse, a Electroencephalogram (EEG). The investigators will use the MIDAS questionnaire Migraine Disability), the HIT-6 Questionnaire (Headache Impact Test) and the FFMQ-BR (Five Facet Mindfulness Questionnaire). The investigators will analyze the data through Statistical Package for Social Sciences (SPSS) 25.0 program for software and from data normality analysis will be applied parametric and / or nonparametric tests.
Discussion: Based on the use of tDCS in patients with chronic pain, and in benefits of Mindfulness practice in these patients, the objective is to evaluate if the mindfulness-associated TCCA provides satisfactory results in the painful prophylaxis of patients with chronic migraine.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aged between twenty-five and fifty years who have been clinically diagnosed with chronic migraine according to the third edition of the International Classification of Headache Disorders (ICHD-3) will be selected.
- •Only patients who are able to complete treatment in the twelve sessions of four preprogrammed consecutive weeks will be accepted, although up to three alternating absences or two excused absences are tolerated.
- •Absent days will be replaced with follow-up on the next working day to minimize dropouts and promote adherence to treatment. Flextime will be provided to participants who receive the therapy, as well as direct contact by calling participants by phone to confirm the evaluation dates and reinforce adherence to treatment.
排除标准
- •Exclusion criteria will be the presence of headache attributed to another neurological or associated neuropsychiatric pathology, the use of central nervous system (CNS)-modulating drugs, the diagnosis of a severe, distinct neurological or psychiatric disease, the use of another nondrug therapy for migraine or other CNS pathologies concurrent with or immediately before the intervention, the presence of metallic implants located in the cephalic region and the implantation of cardiac pacemakers.
结局指标
主要结局
Migraine disabIlity assessment questionnaire - MIDAS
时间窗: 04 weeks
The Migraine Disability Assessment Questionnaire (MIDAS) will be used for this assessment. Its objective is to evaluate the inability of migraine patients to perform daily and professional tasks. This instrument contains five questions that must be completed with the number of days the patient failed to perform the specified activity because he or she was experiencing a migraine episode. This assessment is a useful tool for identifying the severity of this condition. Includes questions that score between 8 and 13 points, depending on the answer given. This questionnaire can be applied to people of different educational and social levels, as it is considered easy to answer (FRAGOSO, 2002).
次要结局
- Five facets of mindfulness questionnaire (FFMQ-BR)(04 weeks)
- Headache impact test - HIT-6(04 weeks)
研究者
Suellen Marinho Andrade
Ph.D
Federal University of Paraíba