NCT04219345

Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation	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.

Timeline

• Start date: 2020-03-30
• Primary completion: 2020-05-30
• Completion: 2020-06-30
• First posted: 2020-01-07
• Last updated: 2020-01-07

Locations

2 sites across 1 country: Brazil