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Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.
NCT00200109 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Occipital Nerve Stimulation
Study Locations (9)
Michigan
- Contact Medtronic for Exact Locations — Ann Arbor
- Contact Medtronic for Exact Locations — Detroit
Arizona
- Contact Medtronic for Exact Location — Scottsdale
California
- Contact Medtronic for Exact Locations — Oceanside
Colorado
- Contact Medtronic for Exact Locations — Denver
Oklahoma
- Contact Medtronic for Exact Locations — Oklahoma City
Pennsylvania
- Contact Medtronic for Exact Locations — Philadelphia
Alberta
- Contact Medtronic for Exact Location — Calgary
Other
- Contact Medtronic for Exact Location — London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2004-05 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00200109
The ClinicalTrials.gov registry entry for NCT00200109 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedtronicNeuro, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Migraine Headache appearing as the primary indexed condition, and to 1 intervention — of which Occipital Nerve Stimulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00200109 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Michigan, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00200109 about?
NCT00200109 is a clinical study titled "Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.". 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 stimulati...
What is the current status of trial NCT00200109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2004-05. Estimated completion is 2011-05.
What conditions does trial NCT00200109 study?
This clinical trial studies the following conditions: Chronic Migraine Headache. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00200109?
The interventions under investigation include: Occipital Nerve Stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00200109?
This trial is sponsored by MedtronicNeuro, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00200109 being conducted?
This trial has 9 study locations across Arizona, California, Colorado, Michigan, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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