Clinical trial NCT02562222: Optimized tDCS for the Treatment of Migraine
Official title: Optimizing the Effect of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Migraine Disorders
Keywords: migraine disorders
transcranial direct current stimulation
electric stimulation therapy
pain
rehabilitation
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes on VAS
timeFrame: through study completion, assessed up to 3 weeks (before and after each section)
Secondary outcomes:
measure: Changes on Visual Evoked Potentials measures
timeFrame: through study completion, assessed up to 3 weeks (before and after each section)
measure: Changes on motor evoked potentials
timeFrame: through study completion, assessed up to 3 weeks (before and after each section)
measure: Changes on intracortical inhibition
timeFrame: through study completion, assessed up to 3 weeks (before and after each section)
measure: Changes on intracortical facilitation
timeFrame: through study completion, assessed up to 3 weeks (before and after each section)
measure: Changes from phosphene threshold
timeFrame: through study completion, assessed up to 3 weeks (before and after each section)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Kátia Monte-Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: