Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
Primary Purpose
Chronic Migraine, Medication Overuse Headache
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anodal transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation
Eligibility Criteria
Inclusion Criteria:
- Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)
Exclusion Criteria:
- Other primary or secondary headaches.
- Any serious systemic or neurological disease or psychiatric disorder.
- Pregnancy or breastfeeding
- Previous or current use of other or similar devices for pain control
- Heart conduction and rhythm disorders
- Cranial surgery
- Other pain conditions, accordingly with current guidelines
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Anodal transcranial direct current stimulation
Sham transcranial direct current stimulation
Control group
Arm Description
Anodal transcranial direct current stimulation
Sham transcranial direct current stimulation
Outcomes
Primary Outcome Measures
Change in headache days per months
Change in drugs intake per months
Secondary Outcome Measures
Change in mean pain intensity score per months
Full Information
NCT ID
NCT01752439
First Posted
December 11, 2012
Last Updated
December 14, 2012
Sponsor
Dr Armando Perrotta, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT01752439
Brief Title
Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
Official Title
Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Armando Perrotta, MD, PhD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Medication Overuse Headache
Keywords
Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anodal transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Anodal transcranial direct current stimulation
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Anodal transcranial direct current stimulation
Other Intervention Name(s)
Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Other Intervention Name(s)
Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
Primary Outcome Measure Information:
Title
Change in headache days per months
Time Frame
at 30, 60 and 90 days after the treatment
Title
Change in drugs intake per months
Time Frame
at 30, 60 and 90 days after treatment
Secondary Outcome Measure Information:
Title
Change in mean pain intensity score per months
Time Frame
at 30, 60 and 90 days after treatment
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:
Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)
Exclusion Criteria:
Other primary or secondary headaches.
Any serious systemic or neurological disease or psychiatric disorder.
Pregnancy or breastfeeding
Previous or current use of other or similar devices for pain control
Heart conduction and rhythm disorders
Cranial surgery
Other pain conditions, accordingly with current guidelines
12. IPD Sharing Statement
Learn more about this trial
Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
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