We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01677026
Recruitment Status : Active, not recruiting
First Posted : August 31, 2012
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Cluster Headache

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
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
Study Start Date : September 2012
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following: [ Time Frame: Through study completion ]
    1. Implantation of ATI Neurostimulator within the pterygopalatine fossa
    2. Explant and lead-revision rates and reasons

  2. Characterization of patient response to therapy, as evaluated by the following: [ Time Frame: 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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01677026     History of Changes
Other Study ID Numbers: CP-004
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

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