Transcranial Direct Current Simulation in Chronic Migraine

NCT02817139 | Unknown Phase 1

• 1 other identifier: migraine
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in pain assessed on the Visual Analogue Scale (VAS)

  Baseline (week 1) and Endpoint (week 4)

• 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)

• Side Effects Questionnaire

  From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month

Study Arms (3)

active tDCS over primary motor cortex

ACTIVE COMPARATOR

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

Device: TDCS

active tDCS over prefrontal cortex

EXPERIMENTAL

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

Device: TDCS

sham tDCS over primary motor cortex

PLACEBO COMPARATOR

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.

Device: TDCS

Interventions

TDCS DEVICE

Also known as: Transcranial Direct Current Stimulation

active tDCS over prefrontal cortex; active tDCS over primary motor cortex; sham tDCS over primary motor cortex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Suellen Andrade

João Pessoa, Paraíba, Brazil

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

BR (1)