Optimized tDCS for the Treatment of Migraine

Universidade Federal de Pernambuco

Status and phase: Unknown; Phase 2

Conditions: Migraine Disorders

Treatments: Procedure: cathodal tDCS on M1 and anodal on V1; Procedure: anodal tDCS on M1; Procedure: cathodal tDCS on V1; Procedure: anodal tDCS on V1; Procedure: cathodal tDCS on M1; Procedure: sham tDCS; Procedure: anodal tDCS on M1 and cathodal on V1

Study type: Interventional

Funder types: Other

Identifiers

NCT02562222

Optimizing_tDCS_Migraine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 7 patient groups

anodal tDCS on M1

Experimental group

Description:

anodal tDCS on left primary motor cortex

Treatment:

Procedure: anodal tDCS on M1

cathodal tDCS on M1

Experimental group

Description:

cathodal tDCS on left primary motor cortex

Treatment:

Procedure: cathodal tDCS on M1

anodal tDCS on V1

Experimental group

Description:

anodal tDCS on visual cortex

Treatment:

Procedure: anodal tDCS on V1

cathodal tDCS on V1

Experimental group

Description:

cathodal tDCS on visual cortex

Treatment:

Procedure: cathodal tDCS on V1

anodal tDCS on M1 and cathodal on V1

Experimental group

Description:

dual tDCS - anodal tDCS on left primary motor cortex and cathodal on visual cortex

Treatment:

Procedure: anodal tDCS on M1 and cathodal on V1

cathodal tDCS on M1 and anodal on V1

Experimental group

Description:

dual tDCS - cathodal tDCS on left primary motor cortex and anodal on visual cortex

Treatment:

Procedure: cathodal tDCS on M1 and anodal on V1

sham tDCS

Sham Comparator group

Description:

sham tDCS

Treatment:

Procedure: sham tDCS