Back to resultsTranscranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional prevention trial for 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.
Sites / Locations
- Suellen Marinho AndradeRecruiting
- Federal University of Paraíba,Department of Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active group
Sham group
Arm Description
In the group A will be administered anodic tDCS and instructed in mindfulness practices.
In the group B will be administered sham tDCS and instructed in mindfulness practices.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04219345
First Posted
September 16, 2019
Last Updated
January 3, 2020
Sponsor
Federal University of Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT04219345
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2020 (Anticipated)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active group
Arm Type
Active Comparator
Arm Description
In the group A will be administered anodic tDCS and instructed in mindfulness practices.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
In the group B will be administered sham tDCS and instructed in mindfulness practices.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Migraine disabIlity assessment questionnaire - MIDAS
Description
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).
Time Frame
04 weeks
Secondary Outcome Measure Information:
Title
Headache impact test - HIT-6
Description
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.
Time Frame
04 weeks
Title
Five facets of mindfulness questionnaire (FFMQ-BR)
Description
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.
Time Frame
04 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Andrade
Phone
986046032
Ext
55 83
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Marinho
Phone
986046032
Ext
55 83
Email
suellenandrade@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Organizational Affiliation
Federal University of Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suellen Marinho Andrade
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58.051-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen M Andrade, Ph.D
Phone
99937-1471
Ext
55 83
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Suellen Andrade, Ph.D
Phone
83 99937-1471
Ext
55
Email
suellenandrade@gmail.com
Facility Name
Federal University of Paraíba,Department of Psychology
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Phone
986046032
Ext
55 83
Email
suellenandrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcranial Direct Current Stimulation Associated With Mindfulness in Chronic Migraine
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