The primary objectives of the Registry are to: 1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and 2. Collect additional evidence to support reimbursement and clinical acceptance and long term follow up
Study Type
OBSERVATIONAL
Enrollment
150
Danish Headache Center
Glostrup Municipality, Denmark
Berlin Charite Hospital
Berlin, Germany
Neurologische Klinik und Poliklinik
Bochum, Germany
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
1. Implantation of ATI Neurostimulator within the pterygopalatine fossa 2. Explant and lead-revision rates and reasons
Time frame: Through study completion
Characterization of patient response to therapy, as evaluated by the following:
1. Patient acceptance of the therapy 2. Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both 3. Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline 4. Subject Overall Evaluation of Therapy 5. Change in use of acute medications compared to Baseline 6. Change in preventive medication use and work status compared to Baseline
Time frame: Through study completion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen
Essen, Germany
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
Universitatsklinikum Jena Klinik f. Neurologie
Jena, Germany
Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes
Kassel, Germany
Migraine- und Kopfschmerzklinik Konigstein
Königstein, Germany
Neurologie & Kopfschmerzzentrum Munchner Freiheit
Munich, Germany
University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik
Munich, Germany
...and 1 more locations