Pathway CH-1 Long-Term Follow-Up

Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

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.

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.