Clinical trial NCT01677026: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
Official title: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cluster Headache
Lead sponsor: Autonomic Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
timeFrame: Through study completion
measure: Characterization of patient response to therapy, as evaluated by the following:
timeFrame: Through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
city: Berlin
country: Germany
facility: Berlin Charite Hospital
city: Bochum
country: Germany
facility: Neurologische Klinik und Poliklinik
city: Essen
country: Germany
facility: Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen
city: Hamburg
country: Germany
facility: Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
city: Jena
country: Germany
facility: Universitatsklinikum Jena Klinik f. Neurologie
city: Kassel
country: Germany
facility: Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes
city: Konigstein
country: Germany
facility: Migraine- und Kopfschmerzklinik Konigstein
city: Munich
country: Germany
facility: Neurologie & Kopfschmerzzentrum Munchner Freiheit
city: Munich
country: Germany
facility: University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik
city: Munster
country: Germany
facility: Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Study officials:
affiliation: Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
name: Arne May, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: