Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
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
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedDecember 19, 2012
December 1, 2012
10 months
December 11, 2012
December 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in headache days per months
at 30, 60 and 90 days after the treatment
Change in drugs intake per months
at 30, 60 and 90 days after treatment
Secondary Outcomes (1)
Change in mean pain intensity score per months
at 30, 60 and 90 days after treatment
Study Arms (3)
Anodal transcranial direct current stimulation
EXPERIMENTALAnodal transcranial direct current stimulation
Sham transcranial direct current stimulation
SHAM COMPARATORSham transcranial direct current stimulation
Control group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 19, 2012
Study Start
February 1, 2013
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
December 19, 2012
Record last verified: 2012-12