Does tDCS is Effective in the Prophylactic Treatment of Migraine

NCT ID: NCT01886274

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-10-31

Brief Summary

Migraine has been described as one of the most common neurological diseases, with high social and economic impact. Despite the high prevalence, the pathophysiology of migraine is still unknown, several studies have been developed in order to advance the understanding of the pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim of this study is to observe the effects of transcranial direct current stimulation (tDCS), applied in the visual cortex, on neurophysiological and clinical measures (frequency, intensity, duration of attacks and severity of pain) in migraine patients.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS

The experimental group received tDCS to the occipital cortex in 12 sessions, 3 days per week.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The cathodal tDCS decrease the excitability, in this study a constant current of 2 mA intensity was applied for 20 min.

control

The control group received sham stimulation to the occipital cortex in 12 sessions, 3 days per week.

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The cathodal tDCS decrease the excitability, in this study a constant current of 2 mA intensity was applied for 20 min.

healthy subjects

This group was submitted to one evaluation session of cortical excitability.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcranial direct current stimulation

tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The cathodal tDCS decrease the excitability, in this study a constant current of 2 mA intensity was applied for 20 min.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age must be between 18 to 40 years
• Gender: male and female
• Diagnosis must meet the 2004 IHS criteria for migraine without aura and migraine with aura
• Duration of the disease must be at least 12 months
• Patients had no preventative medication consistently for at least six months prior to study initiation.

• Age must be between 18 to 40 years
• Gender: male and female
• Individuals who have not filed headache crisis in the last year assessed according to the 2004 IHS criteria

Exclusion Criteria

• Pregnant woman
• Individuals with clinical evidence of brain injury
• Metallic implant head
• Pacemaker
• History of seizure and chronic pain associated with other pathologies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Kátia Monte-Silva

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Applied Neuroscience Laboratory-LANA

Recife, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Kátia Karina Monte-Silva, Dr

Role: CONTACT

monte.silvakk@gmail.com

21267579

Other Identifiers

Migraine_tDCS

Identifier Type: -

Identifier Source: org_study_id