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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407992
First Posted: December 5, 2006
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Serra Gerardo, Ospedale Sacro Cuore - Don Calabria
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Number and the type of adverse events [ Time Frame: Study period ]
  • Reduction of headache frequency and intensity [ Time Frame: Study period ]

Secondary Outcome Measures:
  • Reduction in drug intake [ Time Frame: Study period ]
  • Changes in QoL and interference in everyday activities [ Time Frame: Study period ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Serra Gerardo, Medical doctor, Ospedale Sacro Cuore - Don Calabria
ClinicalTrials.gov Identifier: NCT00407992     History of Changes
Other Study ID Numbers: MFGGL113006
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Serra Gerardo, Ospedale Sacro Cuore - Don Calabria:
Headache
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms


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