tDCS for the Treatment of Migraine

Universidade Federal de Pernambuco

Status and phase: Unknown; Phase 2

Conditions: Migraine Disorders

Treatments: Device: tdcs

Study type: Interventional

Funder types: Other

Identifiers

NCT02562196

Effect_tDCS_Migraine

Details and patient eligibility

About

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.

Full 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).

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

optimized protocol chosen

Experimental group

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. An interval of 48hs between sessions will be taken.

Treatment:

Device: tdcs

sham tDCS

Sham Comparator group

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. An interval of 48hs between sessions will be taken.

Treatment:

Device: tdcs