The CryoGem Trial is a research study that tests a freezing technique called cryoneurolysis to see if it helps relieve pain in adults with trigeminal neuralgia. Trigeminal neuralgia is a condition that causes severe facial pain. In this study, we want to find out if the freezing technique is effective and safe. We will do this by comparing two groups of adults with trigeminal neuralgia. One group will receive the actual treatment, while the other group will receive a fake treatment called a sham. Neither the participants nor the assessors will know which group they are in (this is called a blinded study). For the next four weeks, participants in both groups will continue recording their headaches without knowing which treatment they are receiving. After this initial period, there will be an extension period where all participants can receive treatment as needed for up to two years. The results of this study will help us decide if the freezing technique is a viable treatment option for trigeminal neuralgia. Our main goal is to see how many people in each group have a significant reduction in pain (at least 75% less pain). We will also record other important information about the participants.
We are looking to recruit up to 24 adults with trigeminal neuralgia to take part in this study. All participants will keep a daily diary for two weeks to track their headaches before starting the treatment. Then, they will be randomly assigned to either the treatment group or the sham group.
Participant must be 18 years at the time of signing the informed consent
A diagnosis of primary (classic and idiopathic) trigeminal neuralgia affecting the mandibular and/or maxillary division, verified by a neurologist
Ability to subclassify the trigeminal neuralgia according to the The International Classification of Headache Disorders, 3rd edition, i.e. sufficient magnetic resonance (MR) evaluation is mandatory
History of minimum mean of three trigeminal neuralgia related pain paroxysms per day last 4 weeks
Diagnosed with demyelinating inflammatory disorders such as e.g. multiple sclerosis.
Other pain conditions, not intended to be treated in this study, that in the opinion of the investigator could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints.
High probability of neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.
Patients exhibiting a high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator.
Parallel
Cryoneurolysis
DeviceCryoneurolysis
Stimulation
DeviceStimulation
Average daily pain
Difference in number of treatment responders (≥ 75% reduction in the mean average daily pain intensity on a NRS score) at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline in the treatment versus the sham group.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of treatment-emergent adverse events and serious adverse events.
50% responders
Difference in number of treatment responders (≥ 50% reduction in the mean average daily pain intensity on a Numeric Rating Scale (NRS) score at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline) in the treatment versus the sham group.
100% responders
Difference in number of complete responders (100% reduction in the mean average daily pain intensity on a NRS score at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline) in the active arm versus the sham arm.
Patient Global Impression of Change (PGI-C) scale responders (a PGI- C responder is defined as having a response of "much improved" or "very much improved" at week 4.)
Difference in number of PGI-C responders corresponding to the treated branch at week 4 in the active arm versus sham arm.
Barrow Institute of (BNI- P) responders (a clinically significant response is defined as having BNI I - BNI IIIb at week 4).
Difference in number of clinically significant BNI-P responders at week 4 in the active arm versus sham arm.
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