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

Not Applicable
Completed
Conditions
Chronic Migraine
Interventions
Other: tDCS
Registration Number
NCT03414203
Lead Sponsor
Federal University of Paraíba
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
31
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sham tDCStDCSSham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region
active tDCStDCSActive tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region
active tDCS with intervaltDCSActive 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
Primary Outcome Measures
NameTimeMethod
Migraine Disability Assessment - MIDAS"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.

Secondary Outcome Measures
NameTimeMethod
Wechsler Intelligence Scale Numbers Test"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Numbers Test

Visual Attention Test (Attention Matrices)"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in selective attention assessed on the Visual Attention Test (Attention Matrices)

Headache Impact Test - HIT-6"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)

Nine Hole Peg Test"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in the motor processing speed assessed on the Nine Hole Peg Test

Concentrated Attention Test"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in selective attention assessed on the Concentrated Attention Test

Montreal Cognitive Assessment"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in cognition assessed on the Montreal Cognitive Assessment

Side Effects Questionnaire"every day for up to 2 weeks"

adverse effects assessment

Trail Making Test part B"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in executive functions assessed on the Trail Making Test part B

Hayling's Test Hayling's Test"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in operational memory assessed on the Hayling's Test Evaluate operational memory

Salthouse Visual Patterns and Lyrics"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in visual processing speed assessed on the Salthouse Visual Patterns and Lyrics

Wechsler Intelligence Scale Letters"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters

Paced Auditory Serial Addition Task"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"

Change in selective attention assessed on the Paced Auditory Serial Addition Task

Trial Locations

Locations (1)

Federal University of Paraiba

🇧🇷

João Pessoa, Paraiba, Brazil

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