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Optimized tDCS for the Treatment of Migraine

Primary Purpose

Migraine Disorders

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
anodal tDCS on M1
cathodal tDCS on M1
anodal tDCS on V1
cathodal tDCS on V1
anodal tDCS on M1 and cathodal on V1
cathodal tDCS on M1 and anodal on V1
sham tDCS
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring migraine disorders, transcranial direct current stimulation, electric stimulation therapy, pain, rehabilitation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages: 18-55 years
  • Gender: Both
  • Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of 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

Sites / Locations

  • Applied Neuroscience LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

anodal tDCS on M1

cathodal tDCS on M1

anodal tDCS on V1

cathodal tDCS on V1

anodal tDCS on M1 and cathodal on V1

cathodal tDCS on M1 and anodal on V1

sham tDCS

Arm Description

anodal tDCS on left primary motor cortex

cathodal tDCS on left primary motor cortex

anodal tDCS on visual cortex

cathodal tDCS on visual cortex

dual tDCS - anodal tDCS on left primary motor cortex and cathodal on visual cortex

dual tDCS - cathodal tDCS on left primary motor cortex and anodal on visual cortex

sham tDCS

Outcomes

Primary Outcome Measures

Changes on VAS
this scale will be used to measure the patients' pain intensity. VAS is an important instrument to verify, reliably, the patient's evolution during treatment. This scale will be used at beginning and end of each period (observation and treatment), before and after each tDCS session. For the VAS use, pain intensity will be asked to the patient. 0 cm means total pain absence and 10 cm is the level of maximum pain bearable by the patient.

Secondary Outcome Measures

Changes on Visual Evoked Potentials measures
volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz. Electrodes used to record data will be localized on Oz and Fz points according International 10-20 system. During the test, 600 cortical answers will be recorded. Data will be collected and recorded in a personal computer, and after, converted to the ".txt" format to futures analysis with MATLAB.
Changes on motor evoked potentials
to measure MEP, the intensity of the magnetic stimulator will be adjusted to 120% of rest motor threshold and 10 stimuli will be registered. For evaluation volunteers will be instructed to sit in a chair and get into a comfortable position. Initially, single-pulse TMS will be administered over the motor cortex to determine the cortical representation area of the first dorsal interosseous muscle (FDI). For all evaluations the same figure-eight coil is used, in order to avoid measurement bias. Amplitude means of evoked potentials will determine the MEP.
Changes on intracortical inhibition
to evaluate these variables, subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at an inter stimulus intervals (ISI) of 2 milliseconds, to determine the short interval cortical inhibition (SICI). The Intracortical facilitation (ICF) will be evaluated by the MEP average at an ISI of 10 milliseconds. Ten stimulus will be applied in each condition (unconditioned pulse, and pairs of stimuli with ISI of 2 and 10 milliseconds). The order of stimulus delivered will be pseudorandomized and SICI and ICF will be expressed as a percentage of a conditioned stimuli in regarding an unconditioned stimuli.
Changes on intracortical facilitation
to evaluate these variables, subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at an inter stimulus intervals (ISI) of 2 milliseconds, to determine the short interval cortical inhibition (SICI). The Intracortical facilitation (ICF) will be evaluated by the MEP average at an ISI of 10 milliseconds. Ten stimulus will be applied in each condition (unconditioned pulse, and pairs of stimuli with ISI of 2 and 10 milliseconds). The order of stimulus delivered will be pseudorandomized and SICI and ICF will be expressed as a percentage of a conditioned stimuli in regarding an unconditioned stimuli.
Changes 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 TMS 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.

Full Information

First Posted
September 22, 2015
Last Updated
May 10, 2016
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02562222
Brief Title
Optimized tDCS for the Treatment of Migraine
Official Title
Optimizing the Effect of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
April 2018 (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
The aim of this study is to establish an optimized protocol of tDCS that normalize the lack of habituation and efficiency of inhibitory cortical circuits in migraine patients and determine tDCS polarity and the best cortical areas to stimulate which could normalize the lack of habituation and efficiency of inhibitory cortical circuits. For this, migraineurs volunteers will undergo to some tDCS protocols or sham tDCS.
Detailed Description
A crossover trial to establish an optimized tDCS protocol will be accomplished. Anodal and cathodal tDCS will be applied over the primary motor cortex (C3 - active and contralateral supra-orbital region - reference) and visual cortex (Oz - active and Cz - reference). Dual tDCS (anodal and cathodal - optimized protocol) will be applied on C3 - active and Oz - active. Electrical cortical activity will be assessed on 14 migraineurs through: (i) MEP; (ii) MT; (iii) SICI; (iv) ICF; (v) PT and (vi) visual evoked-potential (VEP-habituation). An interval of 48hs between sessions will be taken. The order of the sessions will be randomized and counterbalanced among volunteers by site www.randomization.com.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
migraine disorders, transcranial direct current stimulation, electric stimulation therapy, pain, rehabilitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS on M1
Arm Type
Experimental
Arm Description
anodal tDCS on left primary motor cortex
Arm Title
cathodal tDCS on M1
Arm Type
Experimental
Arm Description
cathodal tDCS on left primary motor cortex
Arm Title
anodal tDCS on V1
Arm Type
Experimental
Arm Description
anodal tDCS on visual cortex
Arm Title
cathodal tDCS on V1
Arm Type
Experimental
Arm Description
cathodal tDCS on visual cortex
Arm Title
anodal tDCS on M1 and cathodal on V1
Arm Type
Experimental
Arm Description
dual tDCS - anodal tDCS on left primary motor cortex and cathodal on visual cortex
Arm Title
cathodal tDCS on M1 and anodal on V1
Arm Type
Experimental
Arm Description
dual tDCS - cathodal tDCS on left primary motor cortex and anodal on visual cortex
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
sham tDCS
Intervention Type
Procedure
Intervention Name(s)
anodal tDCS on M1
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
cathodal tDCS on M1
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
anodal tDCS on V1
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
cathodal tDCS on V1
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
anodal tDCS on M1 and cathodal on V1
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
cathodal tDCS on M1 and anodal on V1
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
sham tDCS
Intervention Description
The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites. To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds.
Primary Outcome Measure Information:
Title
Changes on VAS
Description
this scale will be used to measure the patients' pain intensity. VAS is an important instrument to verify, reliably, the patient's evolution during treatment. This scale will be used at beginning and end of each period (observation and treatment), before and after each tDCS session. For the VAS use, pain intensity will be asked to the patient. 0 cm means total pain absence and 10 cm is the level of maximum pain bearable by the patient.
Time Frame
through study completion, assessed up to 3 weeks (before and after each section)
Secondary Outcome Measure Information:
Title
Changes on Visual Evoked Potentials measures
Description
volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz. Electrodes used to record data will be localized on Oz and Fz points according International 10-20 system. During the test, 600 cortical answers will be recorded. Data will be collected and recorded in a personal computer, and after, converted to the ".txt" format to futures analysis with MATLAB.
Time Frame
through study completion, assessed up to 3 weeks (before and after each section)
Title
Changes on motor evoked potentials
Description
to measure MEP, the intensity of the magnetic stimulator will be adjusted to 120% of rest motor threshold and 10 stimuli will be registered. For evaluation volunteers will be instructed to sit in a chair and get into a comfortable position. Initially, single-pulse TMS will be administered over the motor cortex to determine the cortical representation area of the first dorsal interosseous muscle (FDI). For all evaluations the same figure-eight coil is used, in order to avoid measurement bias. Amplitude means of evoked potentials will determine the MEP.
Time Frame
through study completion, assessed up to 3 weeks (before and after each section)
Title
Changes on intracortical inhibition
Description
to evaluate these variables, subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at an inter stimulus intervals (ISI) of 2 milliseconds, to determine the short interval cortical inhibition (SICI). The Intracortical facilitation (ICF) will be evaluated by the MEP average at an ISI of 10 milliseconds. Ten stimulus will be applied in each condition (unconditioned pulse, and pairs of stimuli with ISI of 2 and 10 milliseconds). The order of stimulus delivered will be pseudorandomized and SICI and ICF will be expressed as a percentage of a conditioned stimuli in regarding an unconditioned stimuli.
Time Frame
through study completion, assessed up to 3 weeks (before and after each section)
Title
Changes on intracortical facilitation
Description
to evaluate these variables, subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at an inter stimulus intervals (ISI) of 2 milliseconds, to determine the short interval cortical inhibition (SICI). The Intracortical facilitation (ICF) will be evaluated by the MEP average at an ISI of 10 milliseconds. Ten stimulus will be applied in each condition (unconditioned pulse, and pairs of stimuli with ISI of 2 and 10 milliseconds). The order of stimulus delivered will be pseudorandomized and SICI and ICF will be expressed as a percentage of a conditioned stimuli in regarding an unconditioned stimuli.
Time Frame
through study completion, assessed up to 3 weeks (before and after each section)
Title
Changes 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 TMS 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.
Time Frame
through study completion, assessed up to 3 weeks (before and after each section)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages: 18-55 years Gender: Both Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kátia Monte-Silva, PhD
Email
monte.silvakk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sérgio Rocha, MsC
Email
srocha3105@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kátia Monte-Silva, PhD
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Neuroscience Laboratory
City
Recife
State/Province
Pernambuco
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Rocha
Email
srocha3105@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Optimized tDCS for the Treatment of Migraine

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