Back to resultsTranscranial Direct Current Simulation in Chronic Migraine
Primary Purpose
Migraine Disorders
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
TDCS
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility Criteria
Inclusion Criteria:
- patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.
Exclusion Criteria:
- headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.
Sites / Locations
- Suellen AndradeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
active tDCS over primary motor cortex
active tDCS over prefrontal cortex
sham tDCS over primary motor cortex
Arm Description
Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.
Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.
Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex.
Outcomes
Primary Outcome Measures
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Secondary Outcome Measures
Change in pain assessed on the Visual Analogue Scale (VAS)
Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)
Side Effects Questionnaire
Full Information
NCT ID
NCT02817139
First Posted
June 22, 2016
Last Updated
June 25, 2016
Sponsor
Federal University of Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT02817139
Brief Title
Transcranial Direct Current Simulation in Chronic Migraine
Official Title
Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
4. Oversight
5. Study Description
Brief Summary
This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.
Detailed Description
The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS over primary motor cortex
Arm Type
Active Comparator
Arm Description
Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.
Arm Title
active tDCS over prefrontal cortex
Arm Type
Experimental
Arm Description
Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.
Arm Title
sham tDCS over primary motor cortex
Arm Type
Placebo Comparator
Arm Description
Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex.
Intervention Type
Device
Intervention Name(s)
TDCS
Other Intervention Name(s)
Transcranial Direct Current Stimulation
Primary Outcome Measure Information:
Title
Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
Time Frame
Baseline (week 1) and Endpoint (week 4)
Secondary Outcome Measure Information:
Title
Change in pain assessed on the Visual Analogue Scale (VAS)
Time Frame
Baseline (week 1) and Endpoint (week 4)
Title
Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)
Time Frame
Baseline (week 1) and and Endpoint (week 4)
Title
Side Effects Questionnaire
Time Frame
From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.
Exclusion Criteria:
headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.
Facility Information:
Facility Name
Suellen Andrade
City
João Pessoa
State/Province
PB
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Email
suellenandrade@gmail.com
Email
suellenandrade@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Simulation in Chronic Migraine
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