Pathway CH-1 Long-Term Follow-Up
Completed
- Conditions
- Chronic Cluster Headache
- Registration Number
- NCT01616511
- Lead Sponsor
- Autonomic Technologies, Inc.
- Brief Summary
The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
- Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
- 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 or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
- Subject is not suitable for the study for any reason in the judgment of the Investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects. Long-Term
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Servicio de Neurologia, Hospital Clinico Universitario
🇪🇸Valencia, Spain
Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
🇩🇰Glostrup, Copenhagen, Denmark
Headache Research Unit. University Department of Neurology, Citadelle Hospital
🇧🇪Liege, Belgium