Does tDCS is Effective in the Prophylactic Treatment of Migraine

Migraine Clinical Trial

Official title:

Transcranial Direct Current Stimulation in the Visual Cortex of Migraine Patients: Neurophysiological and Clinical Implications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01886274
• Other study ID #: Migraine_tDCS
• Status: Recruiting
• Phase: Phase 2
• First received: June 18, 2013
• Last updated: May 19, 2014
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: Universidade Federal de Pernambuco
• Contact: Kátia Karina Monte-Silva, Dr
• Phone: 21267579
• Email: monte.silvakk[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria for migraine patients:

• 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.

Inclusion criteria for healthy individuals

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Applied Neuroscience Laboratory-LANA	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change from eletroencephalography	Electroencephalography was performed by digital EEG equipment, the sampling rate of 500 Hz, 0.5 Hz high pass filter and low pass 35 Hz to capture brain electrical activity through 23 electrodes on the scalp according to the International 10-20 system.After positioning the electrodes, the subject remained comfortably seated and relaxed, but awake, with eyes closed 30 cm from the photic stimulator and, without any stimulation, EEG was collected for 1 minute (baseline).After the baseline, was collected a sequence of 1 minute record without stimulation followed by 3 seconds to 9 Hz photic stimulation. This sequence is repeated 4 times. After this procedure, the subject received trains of visual stimuli, 20 seconds each, at frequencies of 3, 9, 15, 21 and 27 Hz, 1 minute spaced from each other and totaling 12 minutes evaluation.	At baseline, 1 month and 2 months, 3 months	No
Secondary	Change from pain diary	The diary is a report of the frequency of the migraine attacks, the intensity, the onset and duration of the pain, the number of migraine-related days (the number of days on which the patients had migraine-related symptoms) and the type of analgesics in case of a migraine attack;	3 followed months	No