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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | See protocol |
|
| Group 2 | Other | See protocol |
|
| Group 3 | Other | See protocol |
|
| Group 4 | Other | See protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occipital Nerve Stimulation | Device | Each group had a different plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| A primary endpoint is not identified for this feasibility study. | No primary endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys. | No secondary endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Saper, M.D. | Michigan Head Pain and Neurological Institute, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Medtronic for Exact Location | Scottsdale | Arizona | 85054 | United States | ||
| Contact Medtronic for Exact Locations |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20861241 | Result | 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: 10.1177/0333102410381142. Epub 2010 Sep 22. |
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| Oceanside |
| California |
| 92024 |
| United States |
| Contact Medtronic for Exact Locations | Denver | Colorado | 80045 | United States |
| Contact Medtronic for Exact Locations | Ann Arbor | Michigan | 48104 | United States |
| Contact Medtronic for Exact Locations | Detroit | Michigan | 48202 | United States |
| Contact Medtronic for Exact Locations | Oklahoma City | Oklahoma | 73152 | United States |
| Contact Medtronic for Exact Locations | Philadelphia | Pennsylvania | 19107 | United States |
| Contact Medtronic for Exact Location | Calgary | Alberta | T2N 2T9 | Canada |
| Contact Medtronic for Exact Location | London | United Kingdom |