Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

Phase 1

Completed

• Conditions: Chronic Migraine Headache
• Interventions: Device: Occipital Nerve Stimulation

• Registration Number: NCT00200109
• Lead Sponsor: MedtronicNeuro

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2008-06
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Occipital Nerve Stimulation	See protocol
Group 3	Occipital Nerve Stimulation	See protocol
Group 1	Occipital Nerve Stimulation	See protocol
Group 4	Occipital Nerve Stimulation	See protocol

Primary Outcome Measures

Name	Time	Method
A primary endpoint is not identified for this feasibility study.	No primary endpoint

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys.	No secondary endpoint

Trial Locations

Locations (2)

Contact Medtronic for Exact Location; 🇬🇧 London, United Kingdom

Contact Medtronic for Exact Locations; 🇺🇸 Philadelphia, Pennsylvania, United States