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

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Device: Occipital nerve stimulation ON; Device: Occipital nerve stimulation off

• Registration Number: NCT00407992
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-04
• Study First Submitted QC: 2006-12-04
• Study First Posted: 2006-12-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Occipital nerve stimulation ON	Occipital nerve stimulation ON	-
Occipital nerve stimulation OFF	Occipital nerve stimulation off	-

Primary Outcome Measures

Name	Time	Method
Number and the type of adverse events	Study period
Reduction of headache frequency and intensity	Study period

Secondary Outcome Measures

Name	Time	Method
Reduction in drug intake	Study period
Changes in QoL and interference in everyday activities	Study period

Trial Locations

Locations (1)

Ospedale Sacro Cuore - Don Calabria; 🇮🇹 Negrar, Verona, Italy