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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Autonomic Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01677026
First received: August 29, 2012
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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

Condition
Cluster Headache

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Resource links provided by NLM:


Further study details as provided by Autonomic Technologies, Inc.:

Primary Outcome Measures:
  • Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following: [ Time Frame: Through study completion ] [ Designated as safety issue: Yes ]
    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: [ Time Frame: Through study completion ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677026

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark
Contact: Rigmor Jensen, MD       RIGJ@glo.regionh.dk   
Principal Investigator: Rigmor Jensen, MD         
Germany
Berlin Charite Hospital Recruiting
Berlin, Germany, 10117
Contact: Uwe Reuter, PD Dr. MBA       uwe.reuter@charite.de   
Principal Investigator: Uwe Reuter, PD Dr. MBA         
Neurologische Klinik und Poliklinik Recruiting
Bochum, Germany, 44789
Contact: Philipp Stude, Dr. med       philipp.stude@bergmannsheil.de   
Principal Investigator: Phlipp Stude, Dr. med         
Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: Dagny Holle, PD Dr. med       dagny.holle@uk-essen.de   
Principal Investigator: Dagny Holle, PD Dr. med         
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE) Recruiting
Hamburg, Germany, 20246
Contact: Arne May, MD, PhD       a.may@uke.de   
Principal Investigator: Arne May, MD, PhD         
Universitatsklinikum Jena Klinik f. Neurologie Recruiting
Jena, Germany, 07747
Contact: Peter Storch, MD       peter.storch@med.uni-jena.de   
Principal Investigator: Peter Storch, MD         
Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes Recruiting
Kassel, Germany, 34121
Contact: Andreas Boger, Dr. med       boeger@rkh-kassel.de   
Principal Investigator: Andreas Boger, Dr. med.         
Migraine- und Kopfschmerzklinik Konigstein Recruiting
Konigstein, Germany, D-61462
Contact: Charly Gaul, Dr. med.       c.gaul@migraene-klinik.de   
Principal Investigator: Charly Gaul, Dr. med.         
University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik Recruiting
Munich, Germany
Contact: Andreas Straube, MD       andreas.straube@med.uni-muenchen.de   
Principal Investigator: Andreas Straube, MD         
Neurologie & Kopfschmerzzentrum Munchner Freiheit Recruiting
Munich, Germany, 80802
Contact: Holger Kaube, Dr. med.       holger.kaube@gmail.com   
Principal Investigator: Holger Kaube, Dr. med.         
Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie Recruiting
Munster, Germany, 48149
Contact: Ingo Husstedt, MD    +49-251-8348196      
Principal Investigator: Ingo Husstedt, MD         
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
Principal Investigator: Arne May, MD, PhD Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
  More Information

No publications provided

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01677026     History of Changes
Other Study ID Numbers: CP-004
Study First Received: August 29, 2012
Last Updated: October 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cluster Headache
Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Trigeminal Autonomic Cephalalgias

ClinicalTrials.gov processed this record on October 30, 2014