The purpose of this clinical trial is to evaluate the safety and effectiveness of the Occipital Nerve Stimulation System (ONSS) in treating chronic cluster headache in adults.
The study aims to answer the following questions:
* What adverse events or medical complications occur following ONSS implantation and stimulation? * Does treatment with the ONSS reduce the frequency of cluster headache attacks compared with baseline?
Participant Involvement
Participants will:
* Undergo implantation of the ONSS device. * Use the ONSS for a 48-week treatment period. * Attend scheduled clinic visits for follow-up assessments and device evaluations. * Maintain a diary documenting cluster headache attacks and use of rescue medications. * Complete study-related assessments throughout the study period.
ICHD-3 criteria for chronic cluster headache
Documented history of CCH since at least 1 year
Minimum mean attack frequency of 4 attacks per week at baseline (-4week to +2 week up to implant)
Documented minimum 4 weeks of retrospective cluster headache diary data
Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
History of epilepsy, current treatment of epilepsy
Documented history of cerebrovascular accident (CVA)
Participants suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
Single group
Occipital Nerve Stimulation System
Device48 weeks of daily stimualtion with ONS System
Number of procedure-related or device-related adverse events at 12 weeks
Number of adverse events at 48 weeks
Change in the mean weekly attack frequency
50% Responder rate
Proportion of subjects achieving a ≥ 50% reduction in mean weekly attack frequency compared to baseline
30% Responder rate
Proportion of subjects achieving a ≥ 30% reduction in mean weekly attack frequency compared to baseline
Change in the mean weekly attack intensity compared to baseline
Intensity is assessed using a 5-point ordinal pain scale from 0-no pain to 4-the worst pain
Click on the lead sponsor to view all of their trials.
