Clinical trial NCT02562196: tDCS for the Treatment of Migraine
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) Optimized Protocol 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
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: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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. Electrical cortical activity will be assessed through: (i) motor evoked potential (MEP); (ii) motor threshold (MT); (iii) short interval intracortical inhibition (SICI); (iv) intracortical facilitation (ICF); (v) phosphene threshold (PT) and (vi) visual evoked-potential (VEP-habituation). Clinical outcomes will be evaluated through: (i) headache diary; (ii) visual analog scale (VAS); (iii) Migrainde disability assessment (MIDAS); (iv) Headache Impact Test (HIT-6) and (v) World Health Organization quality of life assessment instrument (WHOQOL BREF).

Eligibility criteria: Inclusion Criteria:

* 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

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: Change in headache diary variables
timeFrame: 3 followed months
Secondary outcomes:
measure: Changes on Visual Evoked Potentials measures
timeFrame: at baseline, 1 month and 2 months, 3 months
measure: Changes on HIT-6
timeFrame: at baseline, 1 month and 2 months, 3 months.
measure: Changes on MIDAS
timeFrame: at baseline, 1 month and 2 months, 3 months.
measure: Changes on VAS
timeFrame: at baseline, 1 month and 2 months, 3 months.
measure: Changes on motor evoked potentials
timeFrame: through study completion, assessed up to 1 month (before and after each section)
measure: Changes on inhibition and facilitation
timeFrame: through study completion, assessed up to 1 month (before and after each section)
measure: Changes from phosphene threshold
timeFrame: through study completion, assessed up to 1 month (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: