Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
active tDCS over primary motor cortex
Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.
Intervention: TDCS (Device)
active tDCS over prefrontal cortex
Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.
Intervention: TDCS (Device)
sham tDCS over primary motor cortex
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.
Intervention: TDCS (Device)
Outcomes
Primary Outcomes
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Time Frame: Baseline (week 1) and Endpoint (week 4)
Secondary Outcomes
- 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))
Investigators
Suellen Marinho Andrade
Professor
Federal University of Paraíba