Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine

NCT ID: NCT04219345

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2020-06-30

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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
double-blind

Study Groups

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Active group

In the group A will be administered anodic tDCS and instructed in mindfulness practices.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

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.

Sham group

In the group B will be administered sham tDCS and instructed in mindfulness practices.

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Mindfulness

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Suellen Marinho Andrade

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suellen Andrade

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraíba

Locations

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Suellen Marinho Andrade

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, Brazil

Site Status NOT_YET_RECRUITING

Countries

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Brazil

Central Contacts

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Suellen Andrade

Role: CONTACT

986046032 ext. 55 83

Suellen Marinho

Role: CONTACT

986046032 ext. 55 83

Facility Contacts

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Suellen M Andrade, Ph.D

Role: primary

99937-1471 ext. 55 83

Suellen Andrade, Ph.D

Role: backup

83 99937-1471 ext. 55

Suellen Andrade

Role: primary

986046032 ext. 55 83

Other Identifiers

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Mindfulness/ tDCS in migraine

Identifier Type: -

Identifier Source: org_study_id

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