Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Completed

• Conditions: Cluster Headache

• Registration Number: NCT01677026
• Lead Sponsor: Autonomic Technologies, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subject meets CE marked labeling for cluster headache.
• Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
• Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
• Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
• Subject is able to provide written informed consent prior to participation in the study.

Exclusion Criteria

• Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.
• Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
• Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:	Through study completion	1. Implantation of ATI Neurostimulator within the pterygopalatine fossa; 2. Explant and lead-revision rates and reasons
Characterization of patient response to therapy, as evaluated by the following:	Through study completion	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

Trial Locations

Locations (11)

Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen; 🇩🇪 Essen, Germany

Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie; 🇩🇪 Munster, Germany

Neurologische Klinik und Poliklinik; 🇩🇪 Bochum, Germany

Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes; 🇩🇪 Kassel, Germany

University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik; 🇩🇪 Munich, Germany

Migraine- und Kopfschmerzklinik Konigstein; 🇩🇪 Konigstein, Germany

Berlin Charite Hospital; 🇩🇪 Berlin, Germany

Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE); 🇩🇪 Hamburg, Germany

Universitatsklinikum Jena Klinik f. Neurologie; 🇩🇪 Jena, Germany

Neurologie & Kopfschmerzzentrum Munchner Freiheit; 🇩🇪 Munich, Germany

Danish Headache Center; 🇩🇰 Glostrup, Denmark