Clinical trial NCT03414203: Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine
Official title: Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Keywords: Transcranial Direct Current Stimulation
Migraine Disorders
Cognitive Symptoms
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Migraine Disability Assessment - MIDAS
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary outcomes:
measure: Headache Impact Test - HIT-6
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Wechsler Intelligence Scale Letters
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Wechsler Intelligence Scale Numbers Test
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Hayling's Test Hayling's Test
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Trail Making Test part B
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Salthouse Visual Patterns and Lyrics
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Nine Hole Peg Test
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Paced Auditory Serial Addition Task
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Concentrated Attention Test
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Visual Attention Test (Attention Matrices)
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Montreal Cognitive Assessment
timeFrame: "before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
measure: Side Effects Questionnaire
timeFrame: "every day for up to 2 weeks"
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraiba
state: Paraiba
Study officials:
affiliation: Federal University of Paraiba
name: Renata Aranha
role: PRINCIPAL_INVESTIGATOR
References: