Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache

• Age from ≥22 years old.

• Subject has been diagnosed with chronic cluster headache according to the 2013 ICHD, 3rd edition (beta version), criterion 3.1.2.

• Subject reports a minimum of 4 cluster attacks per week on the side of their dominant headache laterality. Subjects who report more than 8 attacks per day or attack duration of less than 30 minutes (untreated or unsuccessfully treated) must have been tested to rule out other forms of trigeminal autonomic cephalalgias.

• Both subject and physician judge previously or currently used preventive and/or acute cluster headache treatment to be inadequate.

• Subject is able to distinguish cluster attacks from other headaches (i.e., migraine, tension-type headaches).

• Subject agrees to not use therapy involving TENS or magnetic field treatment while the Neurostimulator is implanted.

• Subject agrees to not participate in supplemental or alternative therapy, including acupuncture and spinal manipulation, from Study Enrollment through the end of the Experimental Period of the study.

• Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) - except to manage tolerability - from Study Enrollment through the Experimental Period of the study.

• Subject agrees not to use any acute medications, including oxygen therapy, for their treatable cluster attacks during the Experimental Period until after they have used SPG stimulation therapy for at least 15 minutes.

• Subject has had a dental examination and cleaning in the past six (6) months.

• Subject has the ability to read and 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.