Transcranial Direct Current Simulation in Chronic Migraine

Phase 1

• Conditions: Migraine Disorders
• Interventions: Device: TDCS

• Registration Number: NCT02817139
• Lead Sponsor: Federal University of Paraíba

Brief Summary

This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.

Detailed Description

The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Primary Completion: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-25
• Last Update Submitted: 2016-06-25
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.

Exclusion Criteria

• headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS over primary motor cortex	TDCS	Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex.
active tDCS over primary motor cortex	TDCS	Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.
active tDCS over prefrontal cortex	TDCS	Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)	Baseline (week 1) and Endpoint (week 4)

Secondary Outcome Measures

Name	Time	Method
Change in pain assessed on the Visual Analogue Scale (VAS)	Baseline (week 1) and Endpoint (week 4)
Side Effects Questionnaire	From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month
Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)	Baseline (week 1) and and Endpoint (week 4)

Trial Locations

Locations (1)

Suellen Andrade; 🇧🇷 João Pessoa, PB, Brazil