An interventional study of Transcranial direct current stimulation in Migraine, sponsored by Federal University of Paraíba. Status unknown at 2 sites in Brazil. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Prevention
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Federal University of Paraíba is the lead sponsor of 72 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
In the group A will be administered anodic tDCS and instructed in mindfulness practices.
Device: Transcranial direct current stimulation
In the group B will be administered sham tDCS and instructed in mindfulness practices.
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.
Also known as: Mindfulness
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).
Time frame: 04 weeks
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.
Time frame: 04 weeks
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.
Time frame: 04 weeks
Plan to share: No
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Federal University of Paraíba