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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200109
First Posted: September 20, 2005
Last Update Posted: October 12, 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):
MedtronicNeuro
  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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.

Resource links provided by NLM:


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 ]

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 ]

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

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:

  • 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
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): 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
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 12, 2011
Last Verified: October 2011

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