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

This study has been completed.

First Received on December 4, 2006. Last Updated on August 29, 2011 History of Changes

Sponsor:	Ospedale Sacro Cuore - Don Calabria
Information provided by (Responsible Party):	Serra Gerardo, Ospedale Sacro Cuore - Don Calabria
ClinicalTrials.gov Identifier:	NCT00407992

Purpose

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

Condition	Intervention	Phase
Headache, Migraine	Device: Occipital nerve stimulation ON Device: Occipital nerve stimulation off	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Ospedale Sacro Cuore - Don Calabria:

Primary Outcome Measures:

Number and the type of adverse events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
Reduction of headache frequency and intensity [ Time Frame: Study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in drug intake [ Time Frame: Study period ] [ Designated as safety issue: No ]
Changes in QoL and interference in everyday activities [ Time Frame: Study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	December 2006
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Occipital nerve stimulation ON	Device: Occipital nerve stimulation ON Implant of an occipital nerve stimulator switched ON
Occipital nerve stimulation OFF	Device: Occipital nerve stimulation off Implant of an occipital nerve stimulator switched OFF

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407992

Locations

Italy
Ospedale Sacro Cuore - Don Calabria
Negrar, Verona, Italy, 37024

Sponsors and Collaborators

Ospedale Sacro Cuore - Don Calabria

Investigators

Principal Investigator:

Gerardo Serra

Ospedale Sacro Cuore - Don Calabria

More Information

No publications provided

Responsible Party:	Serra Gerardo, Medical doctor, Ospedale Sacro Cuore - Don Calabria
ClinicalTrials.gov Identifier:	NCT00407992 History of Changes
Other Study ID Numbers:	MFGGL113006
Study First Received:	December 4, 2006
Last Updated:	August 29, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by Ospedale Sacro Cuore - Don Calabria:

Headache
Migraine

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2012