This trial is active, not recruiting.

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

Study Design

Observational model cohort
Time perspective prospective

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

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Autonomic Technologies, Inc..