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This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. Each trial subject will serve as his/her own control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Therapy | Experimental | Occipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| battery-powered bion(R) microstimulator system | Device | Stimulation on from initial activation and on. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate acceptable rate of adverse events. | Throughout the Study | |
| The primary efficacy measure is a significant reduction in either headache frequency or severity | 4 months Post-Activation Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J. Goadsby, MD | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London - Institute of Neurology | London | WC IN 3BG | United Kingdom |
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| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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