Transcranial Direct Current Simulation in Chronic Migraine

Migraine Disorders Clinical Trial

Official title:

Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817139
• Other study ID #: migraine
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 22, 2016
• Last updated: June 25, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Device:
• TDCS

Locations

Country	Name	City	State
Brazil	Suellen Andrade	João Pessoa	PB

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)		Baseline (week 1) and Endpoint (week 4)	No
Secondary	Change in pain assessed on the Visual Analogue Scale (VAS)		Baseline (week 1) and Endpoint (week 4)	No
Secondary	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)	No
Secondary	Side Effects Questionnaire		From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month	Yes