A Randomized, Parallel Arm, Sham-controlled, Double-blinded, Investigator-initiated Trial to Investigate the Safety and Efficacy of Percutaneous Peripheral Cryoneurolysis Therapy in Medically Refractory Trigeminal Neuralgia: a Pilot Study
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
• History of minimum average daily pain intensity NRS score (ADP) of 4 to10 last 4 weeks
• In baseline minimum average daily pain intensity NRS score (ADP) of 4 to 10
• In baseline minimum mean of three trigeminal neuralgia related pain paroxysms per day
• Treatment refractory as defined in this study as failure to respond, pending an adequate trial in the opinion of the investigator, contraindications or intractable side effect to one of two medications:
∙ Carbamazepine
‣ Oxcarbazepine
• Unaltered prophylactic TN medication regime 2 weeks prior to baseline, and be willing to keep regime unaltered during the baseline and the blinded study period.
⁃ Be an appropriate candidate for the study intervention required in this study on the basis of the clinical judgment of the investigator
⁃ Capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.