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Does tDCS is Effective in the Prophylactic Treatment of Migraine

Primary Purpose

Migraine

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring EEG, migraine, pain, phosphene, tDCs, TMS

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Applied Neuroscience Laboratory-LANARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

tDCS

control

healthy subjects

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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;

Full Information

First Posted
June 18, 2013
Last Updated
May 19, 2014
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01886274
Brief Title
Does tDCS is Effective in the Prophylactic Treatment of Migraine
Official Title
Transcranial Direct Current Stimulation in the Visual Cortex of Migraine Patients: Neurophysiological and Clinical Implications
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
EEG, migraine, pain, phosphene, tDCs, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Description
The experimental group received tDCS to the occipital cortex in 12 sessions, 3 days per week.
Arm Title
control
Arm Type
Sham Comparator
Arm Description
The control group received sham stimulation to the occipital cortex in 12 sessions, 3 days per week.
Arm Title
healthy subjects
Arm Type
No Intervention
Arm Description
This group was submitted to one evaluation session of cortical excitability.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from phosphene threshold
Description
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.
Time Frame
At baseline,1 month, 2 months, 3 months/ per session - at baseline and 30 minutes (after tDCS)
Secondary Outcome Measure Information:
Title
Change from eletroencephalography
Description
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.
Time Frame
At baseline, 1 month and 2 months, 3 months
Title
Change from pain diary
Description
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;
Time Frame
3 followed months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kátia Karina Monte-Silva, Dr
Phone
21267579
Email
monte.silvakk@gmail.com
Facility Information:
Facility Name
Applied Neuroscience Laboratory-LANA
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kátia Karina Monte-Silva, Dr

12. IPD Sharing Statement

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Does tDCS is Effective in the Prophylactic Treatment of Migraine

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