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OpenTrials
Completed

NCT Number: NCT00200109

Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

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.

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Key information

Conditions

Chronic Migraine Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Contact Medtronic for Exact Location, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occipital nerve stimulation

Device

Each group had a different plan

Primary outcomes

  1. A primary endpoint is not identified for this feasibility study.

    Time frame: No primary endpoint

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

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

Acronym: ONSTIM

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Sep 20, 2005
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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