Pathway CH-1 Long-Term Follow-Up
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
First received: June 7, 2012
Last updated: June 29, 2015
Last verified: December 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
Primary Outcome Measures:
- Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects. [ Time Frame: Long-Term ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects who have been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial, who have completed the Pathway CH-1 trial, and who remain implanted with an ATI Neurostimulator.
- 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.
- 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.
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: NCT01616511
|Headache Research Unit. University Department of Neurology, Citadelle Hospital
|Liege, Belgium, B-4000 |
|Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
|Glostrup, Copenhagen, Denmark, DK-2600 |
|Headache Center, Dept. of Neurology, University Duisburg-Essen
|Essen, Germany, 45147 |
|Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
|Hamburg, Germany, 20246 |
|Servicio de Neurologia, Hospital Clinico Universitario
|Valencia, Spain, 46010 |
Autonomic Technologies, Inc.
||Jean Schoenen, MD, PhD
No publications provided
||Autonomic Technologies, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 7, 2012
||June 29, 2015
||Belgium: Federal Agency for Medicinal Products and Health Products
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Central Nervous System Diseases
Headache Disorders, Primary
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias