ONSTIM: Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Group 1 See protocol |
Device: Occipital Nerve Stimulation
Each group had a different plan
|
| Other: Group 2 See protocol |
Device: Occipital Nerve Stimulation
Each group had a different plan
|
| Other: Group 3 See protocol |
Device: Occipital Nerve Stimulation
Each group had a different plan
|
| Other: Group 4 See protocol |
Device: Occipital Nerve Stimulation
Each group had a different plan
|
Outcome Measures
Primary Outcome Measures
- A primary endpoint is not identified for this feasibility study. [No primary endpoint]
Secondary Outcome Measures
- Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys. [No secondary endpoint]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Medtronic for Exact Location | Scottsdale | Arizona | United States | 85054 |
| 2 | Contact Medtronic for Exact Locations | Oceanside | California | United States | 92024 |
| 3 | Contact Medtronic for Exact Locations | Denver | Colorado | United States | 80045 |
| 4 | Contact Medtronic for Exact Locations | Ann Arbor | Michigan | United States | 48104 |
| 5 | Contact Medtronic for Exact Locations | Detroit | Michigan | United States | 48202 |
| 6 | Contact Medtronic for Exact Locations | Oklahoma City | Oklahoma | United States | 73152 |
| 7 | Contact Medtronic for Exact Locations | Philadelphia | Pennsylvania | United States | 19107 |
| 8 | Contact Medtronic for Exact Location | Calgary | Alberta | Canada | T2N 2T9 |
| 9 | Contact Medtronic for Exact Location | London | United Kingdom |
Sponsors and Collaborators
- MedtronicNeuro
Investigators
- Principal Investigator: Joel Saper, M.D., Michigan Head Pain and Neurological Institute, Ann Arbor, MI
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1602