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NCT00407992 Clinical Trial

An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

Headache, Migraine Clinical Trial

— Migraine  

Official title:
An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00407992
Other study ID # MFGGL113006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2006
Est. completion date December 2010

Study information
Verified date September 2019
Source IRCCS Sacro Cuore Don Calabria di Negrar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Occipital nerve stimulation ON
Implant of an occipital nerve stimulator switched ON
• Occipital nerve stimulation off
Implant of an occipital nerve stimulator switched OFF

Locations
Country Name City State
Italy Ospedale Sacro Cuore - Don Calabria Negrar Verona

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number and the type of adverse events Study period
Primary Reduction of headache frequency and intensity Study period
Secondary Reduction in drug intake Study period
Secondary Changes in QoL and interference in everyday activities Study period
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