Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache. (ONSTIM)

Medtronic

Status and phase: Completed; Phase 1

Conditions: Chronic Migraine Headache

Treatments: Device: Occipital Nerve Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00200109

1602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 4 patient groups

Group 1

Other group

Description:

See protocol

Treatment:

Device: Occipital Nerve Stimulation

Group 2

Other group

Description:

See protocol

Treatment:

Device: Occipital Nerve Stimulation

Group 3

Other group

Description:

See protocol

Treatment:

Device: Occipital Nerve Stimulation

Group 4

Other group

Description:

See protocol

Treatment:

Device: Occipital Nerve Stimulation