Pathway CH S&E Registry (SER)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02440776
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Autonomic Technologies, Inc.

Brief Summary:
Monitor the safety and performance of the Pulsante Microstimulator System.

Condition or disease
Cluster Headache

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System
Study Start Date : April 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Primary Outcome Measures :
  1. Characterization of all device/procedure related Adverse Events [ Time Frame: Through five years post implant ]
    Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.

Secondary Outcome Measures :
  1. Acute response to therapy [ Time Frame: Through five years post implant ]
    Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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 Pulsante Microstimulator System

Inclusion Criteria:

  1. Patient meets CE marked labeling for cluster headache.
  2. Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
  3. Patient is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

1. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.

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 identifier (NCT number): NCT02440776

Contact: Carla Griffin 650-395-4229
Contact: Jurgen Hambitzer

Rigshospitalet Neurocenter Recruiting
Glostrup, Denmark, 2600
Contact: Rigmor Jensen, Dr. med    +45 38632062   
Contact: Nunu Lund, Dr.    +45 38632062   
Principal Investigator: Rigmor Jensen, Dr. med         
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie Recruiting
Dresden, Germany, 01307
Contact: Gudrun Goßrau, PD Dr. med    +49 0351-458-2063   
Principal Investigator: Gudrun Goßrau, PD Dr. med         
Heinrich-Heine-University Recruiting
Düsseldorf, Germany, D-40225
Contact: Jan Vesper, Prof. Dr. med.    49 211 81 16058   
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Peter Behrens, Dr. med    0761/270-50010   
Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29 Recruiting
Kassel, Germany, 34121
Contact: Andreas Boger, Dr. med    +43 0561/3086 4601   
Contact: Stephanie Schulze    +49 0561/3086 74183   
Principal Investigator: Andreas Boger, Dr. med         
Neurologie + Kopfschmerzzentrum Münchner Freiheit Recruiting
Munich, Germany, 80802
Contact: Margarete Siemen, Dr. med    +49 (0)89 / 389977-15   
Principal Investigator: Holger Kaube, Dr. med         
Sub-Investigator: Margarete Siemen, Dr. med         
Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna Recruiting
Stockholm, Sweden, 17176
Contact: Anna Steinberg, MD    08-517 753 18   
Contact: Hans Ericson, MD    0733-687799   
University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26 Recruiting
Zurich, Switzerland, 8091
Contact: Jens Petersen, Dr. med    +41 44 255 1111   
United Kingdom
The Walton Center Recruiting
Liverpool, United Kingdom, L97LJ
Contact: Nick Silver, Dr    +44 1515253611   
Contact: Paul Eldridge, Prof    +44 1515253611   
Principal Investigator: Nick Silver, Dr         
Sponsors and Collaborators
Autonomic Technologies, Inc.

Responsible Party: Autonomic Technologies, Inc. Identifier: NCT02440776     History of Changes
Other Study ID Numbers: CP-010
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 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