Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.

Detailed Description
-----------------
The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS for 15 minutes. The tDCS will be applied for 10 days over 2 weeks.

Official Title
-----------------
Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled

Conditions
-----------------
Chronic Migraine

Intervention / Treatment
-----------------
* Other: tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta). Exclusion Criteria: headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease use of central nervous system modulating drugs pregnancy metallic head implants use of a cardiac pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized into 1 of 3 groups: group A: active tDCS for 15 minutes, group B: active tDCS for 15 minutes, with an interval of 20 minutes and group C: more 15 minutes os stimulation, sham tDCS for 15 minutes.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS<br>Active tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region | Other: tDCS<br>* Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.<br>|
| Experimental: active tDCS with interval<br>Active tDCS for 15 minutes, interval of 20 minutes and more 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region | Other: tDCS<br>* Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.<br>|
| Sham Comparator: sham tDCS<br>Sham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region | Other: tDCS<br>* Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Disability Assessment - MIDAS | Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS. | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Impact Test - HIT-6 | Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6) | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Wechsler Intelligence Scale Letters | Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Wechsler Intelligence Scale Numbers Test | Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Numbers Test | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Hayling's Test Hayling's Test | Change in operational memory assessed on the Hayling's Test Evaluate operational memory | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Trail Making Test part B | Change in executive functions assessed on the Trail Making Test part B | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Salthouse Visual Patterns and Lyrics | Change in visual processing speed assessed on the Salthouse Visual Patterns and Lyrics | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Nine Hole Peg Test | Change in the motor processing speed assessed on the Nine Hole Peg Test | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Paced Auditory Serial Addition Task | Change in selective attention assessed on the Paced Auditory Serial Addition Task | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Concentrated Attention Test | Change in selective attention assessed on the Concentrated Attention Test | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Visual Attention Test (Attention Matrices) | Change in selective attention assessed on the Visual Attention Test (Attention Matrices) | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Montreal Cognitive Assessment | Change in cognition assessed on the Montreal Cognitive Assessment | before treatment, after treatment - up to 2 weeks  and up to 1 month after the last day of treatment | 
| Side Effects Questionnaire | adverse effects assessment | every day for up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Direct Current Stimulation, Migraine Disorders, Cognitive Symptoms