Trials / Completed
CompletedNCT00200109
Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Occipital Nerve Stimulation | Each group had a different plan |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2008-06-01
- Completion
- 2011-05-01
- First posted
- 2005-09-20
- Last updated
- 2011-10-12
Locations
9 sites across 3 countries: United States, Canada, United Kingdom
Source: ClinicalTrials.gov record NCT00200109. Inclusion in this directory is not an endorsement.