Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine: a Randomized Clinical Trial

Conditions
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Migraine

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized, double-blind, placebo-controlled clinical trial will analyze patients with a confirmed diagnosis of chronic migraine by a neurologist who were subjected to tDCS associated with mindfulness practices.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active group<br>In the group A will be administered anodic tDCS and instructed in mindfulness practices. | Device: Transcranial direct current stimulation<br>* Both groups will undergo the same protocol of twelve sessions of twenty minutes of tDCS associated with mindfulness, where only the type of received electric current is varied (active or simulated sham type). The twelve sessions will be performed in three sessions per week for four weeks, and mindfulness practice at home will be encouraged on days when the intervention is not administered.<br>* Other names: Mindfulness;|
| Sham Comparator: Sham group<br>In the group B will be administered sham tDCS and instructed in mindfulness practices. | Device: Transcranial direct current stimulation<br>* Both groups will undergo the same protocol of twelve sessions of twenty minutes of tDCS associated with mindfulness, where only the type of received electric current is varied (active or simulated sham type). The twelve sessions will be performed in three sessions per week for four weeks, and mindfulness practice at home will be encouraged on days when the intervention is not administered.<br>* Other names: Mindfulness;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine disabIlity assessment questionnaire - MIDAS | 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). | 04 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache impact test - HIT-6 | HIT-6 is a highly reliable questionnaire validated in Portuguese. It evaluates the frequency of headache impact on the quality of life of patients with chronic and episodic migraine and discriminates the types of migraine presented by the patient (episodic, chronic or non-migratory types). It is simple and easy to apply (Yang et al, 2010). This questionnaire consists of six questions that evaluate these parameters through the following options: never, rarely, sometimes, very often and always. A predetermined value is associated with each of these frequency parameters (for example, the score is rarely 8 points and usually 13 points), which will be added to the final score to determine the score equivalent to the headache impact. | 04 weeks | 
| Five facets of mindfulness questionnaire (FFMQ-BR) | The FFMQ-BR is an instrument for assessing the characteristics of mindfulness validated in Brazil in 2014. Subdivided into five main evaluation factors (observation, description, non-judgment, non-reactivity and conscientious acting) assessed in the situations addressed in each item - For example, In difficult situations, I can pause without reacting immediately. This scenario is classified by the participant through a scale ranging from 1 to 5 points, where 1 represents never or almost never and 5 represents always or almost always (BARROS et al, 2014). The total score of the questionnaire will be calculated and this score will be compared before and after all intervention sessions are completed between the two groups to assess whether the participants' level of attention has increased. | 04 weeks |