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Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache. (ONSTIM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200109
First received: September 12, 2005
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month.

Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.


Condition Intervention Phase
Chronic Migraine Headache
 Device: Occipital Nerve Stimulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • A primary endpoint is not identified for this feasibility study. [ Time Frame: No primary endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys. [ Time Frame: No secondary endpoint ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: May 2004
Study Completion Date: May 2011
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
See protocol
 Device: Occipital Nerve Stimulation
Each group had a different plan
Group 2
See protocol
 Device: Occipital Nerve Stimulation
Each group had a different plan
Group 3
See protocol
 Device: Occipital Nerve Stimulation
Each group had a different plan
Group 4
See protocol
 Device: Occipital Nerve Stimulation
Each group had a different plan

Detailed Description:

The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria
  • compliance with daily questionnaire
  • headache that has not responded to at least two classes of headache medications
  • stable headache medication regimen

Exclusion Criteria:

  • previous surgical procedures to disrupt the nerves of the neck relating to the headache
  • subjects who may require MRI or Diathermy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200109

Locations
United States, Arizona
Contact Medtronic for Exact Location
Scottsdale, Arizona, United States, 85054
United States, California
Contact Medtronic for Exact Locations
Oceanside, California, United States, 92024
United States, Colorado
Contact Medtronic for Exact Locations
Denver, Colorado, United States, 80045
United States, Michigan
Contact Medtronic for Exact Locations
Ann Arbor, Michigan, United States, 48104
Contact Medtronic for Exact Locations
Detroit, Michigan, United States, 48202
United States, Oklahoma
Contact Medtronic for Exact Locations
Oklahoma City, Oklahoma, United States, 73152
United States, Pennsylvania
Contact Medtronic for Exact Locations
Philadelphia, Pennsylvania, United States, 19107
Canada, Alberta
Contact Medtronic for Exact Location
Calgary, Alberta, Canada, T2N 2T9
United Kingdom
Contact Medtronic for Exact Location
London, United Kingdom
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: Joel Saper, M.D. Michigan Head Pain and Neurological Institute, Ann Arbor, MI
  More Information

Publications:

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00200109     History of Changes
Other Study ID Numbers: 1602
Study First Received: September 12, 2005
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

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 June 18, 2013