tDCS for the Treatment of Migraine

NCT ID: NCT02562196

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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).

Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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optimized protocol chosen

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.

Group Type EXPERIMENTAL

tdcs

Intervention Type 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.

sham tDCS

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.

Group Type SHAM_COMPARATOR

tdcs

Intervention Type 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.

Interventions

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tdcs

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kátia Monte-Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Locations

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Applied Neuroscience Laboratory

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Kátia Monte-Silva, PhD

Role: CONTACT

Sérgio Rocha, MsC

Role: CONTACT

Facility Contacts

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Sergio Rocha

Role: primary

Other Identifiers

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Effect_tDCS_Migraine

Identifier Type: -

Identifier Source: org_study_id

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