Back to resultsAn Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache (Migraine)
Primary Purpose
Headache, Migraine
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Occipital nerve stimulation ON
Occipital nerve stimulation off
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Migraine focused on measuring Headache, Migraine
Eligibility Criteria
Inclusion Criteria:
- patients with migraine
- patients 18 years aged or above
Exclusion Criteria:
- patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
- patients pregnant or planning on becoming pregnant during the study period
Sites / Locations
- Ospedale Sacro Cuore - Don Calabria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Occipital nerve stimulation ON
Occipital nerve stimulation OFF
Arm Description
Outcomes
Primary Outcome Measures
Number and the type of adverse events
Reduction of headache frequency and intensity
Secondary Outcome Measures
Reduction in drug intake
Changes in QoL and interference in everyday activities
Full Information
NCT ID
NCT00407992
First Posted
December 4, 2006
Last Updated
September 19, 2019
Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
1. Study Identification
Unique Protocol Identification Number
NCT00407992
Brief Title
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
Acronym
Migraine
Official Title
An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
Headache, Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occipital nerve stimulation ON
Arm Type
Experimental
Arm Title
Occipital nerve stimulation OFF
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Occipital nerve stimulation ON
Intervention Description
Implant of an occipital nerve stimulator switched ON
Intervention Type
Device
Intervention Name(s)
Occipital nerve stimulation off
Intervention Description
Implant of an occipital nerve stimulator switched OFF
Primary Outcome Measure Information:
Title
Number and the type of adverse events
Time Frame
Study period
Title
Reduction of headache frequency and intensity
Time Frame
Study period
Secondary Outcome Measure Information:
Title
Reduction in drug intake
Time Frame
Study period
Title
Changes in QoL and interference in everyday activities
Time Frame
Study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with migraine
patients 18 years aged or above
Exclusion Criteria:
patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
patients pregnant or planning on becoming pregnant during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo Serra
Organizational Affiliation
IRCCS Sacro Cuore Don Calabria di Negrar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Sacro Cuore - Don Calabria
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22622909
Citation
Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.
Results Reference
result
Learn more about this trial
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
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