Pathway CH-1 Long-Term Follow-Up

Autonomic Technologies, Inc.33 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Cluster Headache

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (3)

Headache Research Unit. University Department of Neurology, Citadelle Hospital

Liège, Belgium

Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen

Glostrup, Copenhagen, Denmark, Denmark

Servicio de Neurologia, Hospital Clinico Universitario

Valencia, Spain, Spain

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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