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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started May 2004

Longer than P75 for phase_1

Geographic Reach

3 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7 years study duration

Study Start

First participant enrolled

May 1, 2004

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed

2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed

Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

4.1 years

First QC Date

September 12, 2005

Last Update Submit

October 7, 2011

Conditions

Chronic Migraine Headache

Outcome Measures

Primary Outcomes (1)

A primary endpoint is not identified for this feasibility study.
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.
No secondary endpoint

Study Arms (4)

Group 1

OTHER

See protocol

Device: Occipital Nerve Stimulation

Group 2

OTHER

See protocol

Device: Occipital Nerve Stimulation

Group 3

OTHER

See protocol

Device: Occipital Nerve Stimulation

Group 4

OTHER

See protocol

Device: Occipital Nerve Stimulation

Interventions

Occipital Nerve StimulationDEVICE

Each group had a different plan

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

previous surgical procedures to disrupt the nerves of the neck relating to the headache
subjects who may require MRI or Diathermy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MedtronicNeurolead