Pathway CH-1 Long-Term Follow-Up
This study is enrolling participants by invitation only.
Sponsor:
Autonomic Technologies, Inc.
Information provided by (Responsible Party):
Autonomic Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01616511
First received: June 7, 2012
Last updated: August 29, 2012
Last verified: August 2012
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Purpose
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.
| Condition |
|---|
|
Chronic Cluster Headache |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache |
Resource links provided by NLM:
Further study details as provided by Autonomic Technologies, Inc.:
| Estimated Enrollment: | 43 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Pathway CH-1 Subjects |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616511
Locations
| Belgium | |
| Headache Research Unit. University Department of Neurology, Citadelle Hospital | |
| Liege, Belgium, B-4000 | |
| Denmark | |
| Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen | |
| Glostrup, Copenhagen, Denmark, DK-2600 | |
| Germany | |
| Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE) | |
| Hamburg, Germany, 20246 | |
| Spain | |
| Servicio de Neurologia, Hospital Clinico Universitario | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Autonomic Technologies, Inc.
Investigators
| Principal Investigator: | Jean Schoenen, MD, PhD | Citadelle Hospital |
More Information
No publications provided
| Responsible Party: | Autonomic Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT01616511 History of Changes |
| Other Study ID Numbers: | CP-005 |
| Study First Received: | June 7, 2012 |
| Last Updated: | August 29, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Cluster Headache Headache Trigeminal Autonomic Cephalalgias Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013