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

NCT ID: NCT00407992

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Occipital nerve stimulation ON

Group Type EXPERIMENTAL

Occipital nerve stimulation ON

Intervention Type DEVICE

Implant of an occipital nerve stimulator switched ON

Occipital nerve stimulation OFF

Group Type OTHER

Occipital nerve stimulation off

Intervention Type DEVICE

Implant of an occipital nerve stimulator switched OFF

Interventions

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Occipital nerve stimulation ON

Implant of an occipital nerve stimulator switched ON

Intervention Type DEVICE

Occipital nerve stimulation off

Implant of an occipital nerve stimulator switched OFF

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerardo Serra

Role: PRINCIPAL_INVESTIGATOR

IRCCS Sacro Cuore Don Calabria di Negrar

Locations

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Ospedale Sacro Cuore - Don Calabria

Negrar, Verona, Italy

Site Status

Countries

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Italy

References

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

Reference Type RESULT
PMID: 22622909 (View on PubMed)

Other Identifiers

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MFGGL113006

Identifier Type: -

Identifier Source: org_study_id

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