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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Serra Gerardo, Ospedale Sacro Cuore - Don Calabria
ClinicalTrials.gov Identifier:
NCT00407992
First received: December 4, 2006
Last updated: August 29, 2011
Last verified: August 2011
  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:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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 July 20, 2014