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Monitor the safety and performance of the Pulsante Microstimulator System.
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| Measure | Description | Time Frame |
|---|---|---|
| Characterization of all device/procedure related Adverse Events | Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant. | Through five years post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Acute response to therapy | Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant. | Through five years post implant |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
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Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet Neurocenter | Glostrup Municipality | 2600 | Denmark | |||
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| Dresden |
| 01307 |
| Germany |
| Heinrich-Heine-University | Düsseldorf | D-40225 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29 | Kassel | 34121 | Germany |
| Neurologie + Kopfschmerzzentrum Münchner Freiheit | Munich | 80802 | Germany |
| Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna | Stockholm | 17176 | Sweden |
| University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26 | Zurich | 8091 | Switzerland |
| The Walton Center | Liverpool | L97LJ | United Kingdom |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |