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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Autonomic Technologies, Inc. Identifier:
First received: August 29, 2012
Last updated: September 30, 2015
Last verified: September 2015

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

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)

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.

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 identifier: NCT01677026

Danish Headache Center
Glostrup, Denmark
Berlin Charite Hospital
Berlin, Germany, 10117
Neurologische Klinik und Poliklinik
Bochum, Germany, 44789
Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen
Essen, Germany, 45147
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246
Universitatsklinikum Jena Klinik f. Neurologie
Jena, Germany, 07747
Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes
Kassel, Germany, 34121
Migraine- und Kopfschmerzklinik Konigstein
Konigstein, Germany, D-61462
Neurologie & Kopfschmerzzentrum Munchner Freiheit
Munich, Germany, 80802
University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik
Munich, Germany
Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Munster, Germany, 48149
Sponsors and Collaborators
Autonomic Technologies, Inc.
Principal Investigator: Arne May, MD, PhD Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
  More Information

No publications provided

Responsible Party: Autonomic Technologies, Inc. Identifier: NCT01677026     History of Changes
Other Study ID Numbers: CP-004
Study First Received: August 29, 2012
Last Updated: September 30, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cluster Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias processed this record on November 27, 2015