Pathway CH-1 Long-Term Follow-Up
This trial has been completed.
|Condition||chronic cluster headache|
|Sponsor||Autonomic Technologies, Inc.|
|Start date||June 2012|
|End date||June 2016|
|Trial size||33 participants|
|Trial identifier||NCT01616511, CP-005|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Liege, Belgium||Headache Research Unit. University Department of Neurology, Citadelle Hospital||completed|
|Glostrup, Copenhagen, Denmark||Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen||completed|
|Valencia, Spain||Servicio de Neurologia, Hospital Clinico Universitario||completed|
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
Male or female participants of any age.
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.
|Official title||Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache|
|Principal investigator||Jean Schoenen, MD, PhD|
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