Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06213155

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

Led by St. Olavs Hospital · Updated on 2025-06-19

24

Participants Needed

1

Research Sites

143 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 18 years or older at the time of consent signing
  • Diagnosed with primary (classic or idiopathic) trigeminal neuralgia affecting the mandibular and/or maxillary divisions, confirmed by a neurologist
  • Able to classify trigeminal neuralgia based on the International Classification of Headache Disorders, 3rd edition, with sufficient MRI evaluation
  • Have a history of at least three trigeminal neuralgia pain episodes per day during the last four weeks
  • Have an average daily pain intensity score of 4 to 10 on the numeric rating scale during the last four weeks
  • At baseline, have an average daily pain intensity score of 4 to 10
  • At baseline, have an average of at least three trigeminal neuralgia pain episodes per day
  • Considered treatment refractory due to failure, contraindications, or side effects to carbamazepine or oxcarbazepine
  • Maintain an unchanged preventive trigeminal neuralgia medication regimen for two weeks prior to baseline and agree to keep it unchanged during baseline and blinded study period
  • Be judged an appropriate candidate for the study intervention by the investigator
  • Able to provide signed informed consent and comply with study requirements and restrictions
Not Eligible

You will not qualify if you...

  • Diagnosed with demyelinating inflammatory disorders such as multiple sclerosis
  • Have other pain conditions that may interfere with study procedures or pain evaluation
  • At high risk of neurological deterioration due to other medical conditions
  • Have significant comorbidities or frailty that reduce life expectancy or increase hospitalization risk
  • Have medical conditions like bleeding disorders or thrombophilia that increase procedural risk
  • Have significant untreated addiction to medications, alcohol, or illicit drugs within 6 months
  • Show abnormal pain behavior, inappropriate medication use, or unresolved psychiatric illness affecting pain perception or compliance
  • Have had previous nerve treatments like radiofrequency ablation, balloon compression, gamma knife, or chemical denervation targeting the Gasserian ganglion or trigeminal nerve branches involved
  • Have facial anomalies or trauma making the procedure difficult
  • Have an active oral or dental infection at the injection site
  • Have had major infections or cancers involving the face active or treated in the past 6 months
  • Currently participating in another treatment study
  • Have sensory deficits or pain patterns suggesting trigeminal neuropathy rather than neuralgia
  • Have conductive implants contraindicating nerve stimulation according to the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Olavs University Hospital

Trondheim, Norway

Actively Recruiting

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Research Team

I

Irina Aschehoug

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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