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

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 Overview

• Status: Completed
• Conditions: Cluster Headache

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark
    • Danish Headache Center
• Germany
  • Berlin, Germany, 10117
    • Berlin Charite Hospital
  • Bochum, Germany, 44789
    • Neurologische Klinik und Poliklinik
  • Essen, Germany, 45147
    • Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen
  • Hamburg, Germany, 20246
    • Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
  • Jena, Germany, 07747
    • Universitatsklinikum Jena Klinik f. Neurologie
  • Kassel, Germany, 34121
    • Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes
  • Konigstein, Germany, D-61462
    • Migraine- und Kopfschmerzklinik Konigstein
  • Munich, Germany, 80802
    • Neurologie & Kopfschmerzzentrum Munchner Freiheit
  • Munich, Germany
    • University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik
  • Munster, Germany, 48149
    • Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:	Implantation of ATI Neurostimulator within the pterygopalatine fossa; Explant and lead-revision rates and reasons	Through study completion
Characterization of patient response to therapy, as evaluated by the following:	Patient acceptance of the therapy; 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; Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline; Subject Overall Evaluation of Therapy; Change in use of acute medications compared to Baseline; Change in preventive medication use and work status compared to Baseline	Through study completion

Collaborators and Investigators

• Sponsor: Autonomic Technologies, Inc.
• Investigators: Principal Investigator: Arne May, MD, PhD, Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): April 9, 2018

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: CP-004