Transcranial Direct Current Simulation in Chronic Migraine

Federal University of Paraíba

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Migraine Disorders

Treatments: Device: TDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02817139

migraine

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

active tDCS over primary motor cortex

Active Comparator group

Description:

Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.

Treatment:

Device: TDCS

active tDCS over prefrontal cortex

Experimental group

Description:

Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.

Treatment:

Device: TDCS

sham tDCS over primary motor cortex

Placebo Comparator group

Description:

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.

Treatment:

Device: TDCS