Clinical trial NCT00200109: Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
Official title: ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Migraine Headache
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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

Primary outcomes:
measure: A primary endpoint is not identified for this feasibility study.
timeFrame: No primary endpoint
Secondary outcomes:
measure: Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.
timeFrame: No secondary endpoint
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Contact Medtronic for Exact Location
state: Arizona
city: Oceanside
country: United States
facility: Contact Medtronic for Exact Locations
state: California
city: Denver
country: United States
facility: Contact Medtronic for Exact Locations
state: Colorado
city: Ann Arbor
country: United States
facility: Contact Medtronic for Exact Locations
state: Michigan
city: Detroit
country: United States
facility: Contact Medtronic for Exact Locations
state: Michigan
city: Oklahoma City
country: United States
facility: Contact Medtronic for Exact Locations
state: Oklahoma
city: Philadelphia
country: United States
facility: Contact Medtronic for Exact Locations
state: Pennsylvania
city: Calgary
country: Canada
facility: Contact Medtronic for Exact Location
state: Alberta
city: London
country: United Kingdom
facility: Contact Medtronic for Exact Location
Study officials:
affiliation: Michigan Head Pain and Neurological Institute, Ann Arbor, MI
name: Joel Saper, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ; ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22.