Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

Chronic Migraine Headache Clinical Trial

— ONSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200109
• Other study ID #: 1602
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: October 7, 2011
• Start date: May 2004
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2011
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Chronic Migraine Headache
• Headache
• Migraine Disorders

Intervention

Device:
• Occipital Nerve Stimulation
Each group had a different plan

Locations

Country	Name	City	State
Canada	Contact Medtronic for Exact Location	Calgary	Alberta
United Kingdom	Contact Medtronic for Exact Location	London
United States	Contact Medtronic for Exact Locations	Ann Arbor	Michigan
United States	Contact Medtronic for Exact Locations	Denver	Colorado
United States	Contact Medtronic for Exact Locations	Detroit	Michigan
United States	Contact Medtronic for Exact Locations	Oceanside	California
United States	Contact Medtronic for Exact Locations	Oklahoma City	Oklahoma
United States	Contact Medtronic for Exact Locations	Philadelphia	Pennsylvania
United States	Contact Medtronic for Exact Location	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A primary endpoint is not identified for this feasibility study.		No primary endpoint	No
Secondary	Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.		No secondary endpoint	No