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

October 7, 2011 updated by: MedtronicNeuro

ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Contact Medtronic for exact location
  • United Kingdom
      • London, United Kingdom
        • Contact Medtronic for exact location
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85054
        • Contact Medtronic for exact location
    • California
      • Oceanside, California, United States, 92024
        • Contact Medtronic for Exact Locations
    • Colorado
      • Denver, Colorado, United States, 80045
        • Contact Medtronic for Exact Locations
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Contact Medtronic for Exact Locations
      • Detroit, Michigan, United States, 48202
        • Contact Medtronic for Exact Locations
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73152
        • Contact Medtronic for Exact Locations
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Contact Medtronic for Exact Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
See protocol
Device: Occipital Nerve Stimulation
Each group had a different plan
Other: Group 2
See protocol
Device: Occipital Nerve Stimulation
Each group had a different plan
Other: Group 3
See protocol
Device: Occipital Nerve Stimulation
Each group had a different plan
Other: Group 4
See protocol
Device: Occipital Nerve Stimulation
Each group had a different plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A primary endpoint is not identified for this feasibility study.
Time Frame: No primary endpoint
No primary endpoint

Secondary Outcome Measures

Outcome Measure
Time Frame
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
No secondary endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Principal Investigator: Joel Saper, M.D., Michigan Head Pain and Neurological Institute, Ann Arbor, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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