Clinical trial NCT04219345: Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine
Official title: Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Migraine disabIlity assessment questionnaire - MIDAS
timeFrame: 04 weeks
Secondary outcomes:
measure: Headache impact test - HIT-6
timeFrame: 04 weeks
measure: Five facets of mindfulness questionnaire (FFMQ-BR)
timeFrame: 04 weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Marinho Andrade
state: Paraíba
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba,Department of Psychology
state: Paraíba
Study officials:
affiliation: Federal University of Paraíba
name: Suellen Andrade
role: PRINCIPAL_INVESTIGATOR
References: