Does tDCS is Effective in the Prophylactic Treatment of Migraine

NCT01886274 | Unknown Phase 2 DMC

• 1 other identifier: Migraine_tDCS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

EEG; migraine; pain; phosphene; tDCs; TMS

Outcome Measures

Primary Outcomes (1)

• Change from phosphene threshold

  A 10-cm circular coil was used that has giving a peak magnetic field strength of 2 tesla. Subjects were asked to wear a blindfold, sit comfortably in a chair and to close their eyes to diminish ambient light.In sagittal line, three points were scored: 2, 3 and 4 cm above the inion. The single pulse transcranial magnetic stimulation was applied to one of the points scored and the subject was asked to report the presence or absence of a phosphene immediately after stimulation. The stimulation was repeated ten times at each intensity with a maximum frequency of 0.2 Hz, stimulation was initially applied to 60% of the maximum intensity of the stimulator. The intensity of stimulation was changed into blocks of 5% to minimum intensity that the subject can perceive the phosphene certainly, five times ten, then this value was set as the PT for migraineurs and controls.

  At baseline,1 month, 2 months, 3 months/ per session - at baseline and 30 minutes (after tDCS)

Secondary Outcomes (2)

• Change from eletroencephalography

  At baseline, 1 month and 2 months, 3 months

• Change from pain diary

  3 followed months

Study Arms (3)

tDCS

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

control

SHAM COMPARATOR

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

Device: Transcranial direct current stimulation

healthy subjects

NO INTERVENTION

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

Interventions

Transcranial direct current stimulation 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; tDCS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory-LANA

Recife, Pernambuco, 50740-560, Brazil

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Kátia Karina Monte-Silva, Dr

CONTACT

21267579; monte.silvakk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 25, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

BR (1)