tDCS for the Treatment of Migraine

NCT02562196 | Unknown Phase 2 DMC

• 1 other identifier: Effect_tDCS_Migraine
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate an optimized protocol of tDCS that normalize the lack of habituation and efficiency of inhibitory cortical circuits in migraine patients. For this purpose, migraineurs volunteers will undergo to optimized tDCS protocol or sham tDCS.

Conditions

Migraine Disorders

Keywords

migraine disorders; transcranial direct current stimulation; electric stimulation therapy; pain

Outcome Measures

Primary Outcomes (1)

• Change in headache diary variables

  it will be evaluated the number of migraine attacks, pain intensity, duration of each attack and number of painkillers intake. Patients will answer this diary during all experimental period (months).

  3 followed months

Secondary Outcomes (7)

• Changes on Visual Evoked Potentials measures

  at baseline, 1 month and 2 months, 3 months

• Changes on HIT-6

  at baseline, 1 month and 2 months, 3 months.

• Changes on MIDAS

  at baseline, 1 month and 2 months, 3 months.

• Changes on VAS

  at baseline, 1 month and 2 months, 3 months.

• Changes on motor evoked potentials

  through study completion, assessed up to 1 month (before and after each section)

Study Arms (2)

optimized protocol chosen

EXPERIMENTAL

a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with optimal protocol (defined in phase 1) and sham tDCS will be conducted to evaluated electrical cortical activity and pain control, number of migraine attacks and quality of life of migraine patients. An interval of 48hs between sessions will be taken.

Device: tdcs

sham tDCS

SHAM COMPARATOR

a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with optimal protocol (defined in phase 1) and sham tDCS will be conducted to evaluated electrical cortical activity and pain control, number of migraine attacks and quality of life of migraine patients. An interval of 48hs between sessions will be taken.

Device: tdcs

Interventions

tdcs DEVICE

The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.

optimized protocol chosen; sham tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of International Classification of Headache Disorders (ICHD-III)
• Disease duration of at least 12 months
• Without preventive medication for at least 6 months prior to initiation of treatment

You may not qualify if:

• Pregnant women;
• Pacemaker;
• History of seizures;
• Metallic implants in the head;
• Patients with clinical evidence of brain injuries;
• Chronic pain associated to others diseases;
• Use of neuroleptic medications

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, Brazil

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kátia Monte-Silva, PhD

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kátia Monte-Silva, PhD

CONTACT

monte.silvakk@gmail.com

Sérgio Rocha, MsC

CONTACT

srocha3105@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Transcranial Direct Current Stimulation (tDCS) Optimized Protocol for the Treatment of Migraine

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 29, 2015
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: April 1, 2018
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

BR (1)