Skip to main content
Clinical Trials/NCT02562222
NCT02562222
Unknown
Phase 2

Optimizing the Effect of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Migraine

Universidade Federal de Pernambuco1 site in 1 country14 target enrollmentMay 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Migraine Disorders
Sponsor
Universidade Federal de Pernambuco
Enrollment
14
Locations
1
Primary Endpoint
Changes on VAS
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study is to establish an optimized protocol of tDCS that normalize the lack of habituation and efficiency of inhibitory cortical circuits in migraine patients and determine tDCS polarity and the best cortical areas to stimulate which could normalize the lack of habituation and efficiency of inhibitory cortical circuits. For this, migraineurs volunteers will undergo to some tDCS protocols or sham tDCS.

Detailed Description

A crossover trial to establish an optimized tDCS protocol will be accomplished. Anodal and cathodal tDCS will be applied over the primary motor cortex (C3 - active and contralateral supra-orbital region - reference) and visual cortex (Oz - active and Cz - reference). Dual tDCS (anodal and cathodal - optimized protocol) will be applied on C3 - active and Oz - active. Electrical cortical activity will be assessed on 14 migraineurs through: (i) MEP; (ii) MT; (iii) SICI; (iv) ICF; (v) PT and (vi) visual evoked-potential (VEP-habituation). An interval of 48hs between sessions will be taken. The order of the sessions will be randomized and counterbalanced among volunteers by site www.randomization.com.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
April 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kátia Monte-Silva

Principal Investigator

Universidade Federal de Pernambuco

Eligibility Criteria

Inclusion Criteria

  • Ages: 18-55 years
  • Gender: Both
  • Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of ICHD-III
  • Disease duration of at least 12 months
  • Without preventive medication for at least 6 months prior to initiation of treatment

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Changes on VAS

Time Frame: through study completion, assessed up to 3 weeks (before and after each section)

this scale will be used to measure the patients' pain intensity. VAS is an important instrument to verify, reliably, the patient's evolution during treatment. This scale will be used at beginning and end of each period (observation and treatment), before and after each tDCS session. For the VAS use, pain intensity will be asked to the patient. 0 cm means total pain absence and 10 cm is the level of maximum pain bearable by the patient.

Secondary Outcomes

  • Changes on Visual Evoked Potentials measures(through study completion, assessed up to 3 weeks (before and after each section))
  • Changes from phosphene threshold(through study completion, assessed up to 3 weeks (before and after each section))
  • Changes on motor evoked potentials(through study completion, assessed up to 3 weeks (before and after each section))
  • Changes on intracortical inhibition(through study completion, assessed up to 3 weeks (before and after each section))
  • Changes on intracortical facilitation(through study completion, assessed up to 3 weeks (before and after each section))

Study Sites (1)

Loading locations...

Similar Trials