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Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache. (ONSTIM)
This study has been completed.
Sponsor:
MedtronicNeuro
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200109
First received: September 12, 2005
Last updated: October 7, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Chronic Migraine Headache | Device: Occipital Nerve Stimulation | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
| Official Title: | ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine. |
Resource links provided by NLM:
Further study details as provided by MedtronicNeuro:
Primary Outcome Measures:
- A primary endpoint is not identified for this feasibility study. [ Time Frame: 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. [ Time Frame: No secondary endpoint ]
| Enrollment: | 110 |
| Study Start Date: | May 2004 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1
See protocol
|
Device: Occipital Nerve Stimulation
Each group had a different plan
|
|
Group 2
See protocol
|
Device: Occipital Nerve Stimulation
Each group had a different plan
|
|
Group 3
See protocol
|
Device: Occipital Nerve Stimulation
Each group had a different plan
|
|
Group 4
See protocol
|
Device: Occipital Nerve Stimulation
Each group had a different plan
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200109
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200109
Locations
| United States, Arizona | |
| Contact Medtronic for Exact Location | |
| Scottsdale, Arizona, United States, 85054 | |
| United States, California | |
| Contact Medtronic for Exact Locations | |
| Oceanside, California, United States, 92024 | |
| United States, Colorado | |
| Contact Medtronic for Exact Locations | |
| Denver, Colorado, United States, 80045 | |
| United States, Michigan | |
| Contact Medtronic for Exact Locations | |
| Ann Arbor, Michigan, United States, 48104 | |
| Contact Medtronic for Exact Locations | |
| Detroit, Michigan, United States, 48202 | |
| United States, Oklahoma | |
| Contact Medtronic for Exact Locations | |
| Oklahoma City, Oklahoma, United States, 73152 | |
| United States, Pennsylvania | |
| Contact Medtronic for Exact Locations | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Canada, Alberta | |
| Contact Medtronic for Exact Location | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| United Kingdom | |
| 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 |
More Information
Publications:
| Responsible Party: | MedtronicNeuro |
| ClinicalTrials.gov Identifier: | NCT00200109 History of Changes |
| Other Study ID Numbers: |
1602 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 7, 2011 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 18, 2017