Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine

NCT04219345 | Unknown

• 1 other identifier: Mindfulness/ tDCS in migraine
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Headache impact test - HIT-6

  04 weeks

• Five facets of mindfulness questionnaire (FFMQ-BR)

  04 weeks

Study Arms (2)

Active group

ACTIVE COMPARATOR

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

Device: Transcranial direct current stimulation

Sham group

SHAM COMPARATOR

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

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation 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.

Also known as: Mindfulness

Active group; Sham group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (2)

Suellen Marinho Andrade

João Pessoa, Paraíba, 58.051-900, Brazil

RECRUITING

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, 58051-900, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Suellen Andrade

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suellen Andrade

CONTACT

986046032; suellenandrade@gmail.com

Suellen Marinho

CONTACT

986046032; suellenandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: January 7, 2020
• Study Start: March 30, 2020
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)