Optimized tDCS for the Treatment of Migraine
Optimizing the Effect of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Migraine
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 11, 2016
May 1, 2016
3 months
September 22, 2015
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
through study completion, assessed up to 3 weeks (before and after each section)
Secondary Outcomes (5)
Changes on Visual Evoked Potentials measures
through study completion, assessed up to 3 weeks (before and after each section)
Changes on motor evoked potentials
through study completion, assessed up to 3 weeks (before and after each section)
Changes on intracortical inhibition
through study completion, assessed up to 3 weeks (before and after each section)
Changes on intracortical facilitation
through study completion, assessed up to 3 weeks (before and after each section)
Changes from phosphene threshold
through study completion, assessed up to 3 weeks (before and after each section)
Study Arms (7)
anodal tDCS on M1
EXPERIMENTALanodal tDCS on left primary motor cortex
cathodal tDCS on M1
EXPERIMENTALcathodal tDCS on left primary motor cortex
anodal tDCS on V1
EXPERIMENTALanodal tDCS on visual cortex
cathodal tDCS on V1
EXPERIMENTALcathodal tDCS on visual cortex
anodal tDCS on M1 and cathodal on V1
EXPERIMENTALdual tDCS - anodal tDCS on left primary motor cortex and cathodal on visual cortex
cathodal tDCS on M1 and anodal on V1
EXPERIMENTALdual tDCS - cathodal tDCS on left primary motor cortex and anodal on visual cortex
sham tDCS
SHAM COMPARATORsham tDCS
Interventions
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Neuroscience Laboratory
Recife, Pernambuco, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kátia Monte-Silva, PhD
Universidade Federal de Pernambuco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 29, 2015
Study Start
May 1, 2016
Primary Completion
August 1, 2016
Study Completion
April 1, 2018
Last Updated
May 11, 2016
Record last verified: 2016-05