NCT06213155

A Study to Investigate the Efficacy of Pain Reduction With Cryoneurolysis Compared With Sham-treatment in Adults With Trigeminal Neuralgia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DEVICE	Cryoneurolysis	Cryoneurolysis
DEVICE	Stimulation	Stimulation

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-12-31
• Completion: 2026-12-01
• First posted: 2024-01-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Norway