Actively Recruiting
A Randomized, Sham-Controlled, Double-Blinded Trial of Percutaneous Peripheral Cryoneurolysis Therapy in Adults With Medically Refractory Trigeminal Neuralgia
Led by St. Olavs Hospital · Updated on 2025-06-19
24
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a freezing technique called cryoneurolysis to see if it helps reduce pain in adults with trigeminal neuralgia, a condition causing severe facial pain. The study is a randomized, triple-blinded trial comparing the freezing treatment with a sham procedure to determine its safety and effectiveness. Researchers want to find out how many participants experience at least a 75% reduction in pain and will also collect other important information about pain relief and side effects. Participants will be randomly assigned to either receive the cryoneurolysis treatment or a sham stimulation device. Before treatment, all participants will keep a daily headache diary for two weeks. After treatment, they will continue recording pain for four weeks. Following this initial period, there is an extension phase lasting up to two years where all participants can receive treatment as needed. The study involves careful monitoring of pain levels and any treatment-related adverse events during weeks 1 to 4 post-intervention. During the study, participants will have their pain recorded daily using pain scales and diaries. Researchers will evaluate average daily pain intensity, responder rates based on various pain and impression scales, and safety outcomes. The study includes baseline and follow-up assessments to compare pain levels before and after treatment. Participants' ability to maintain their usual medication regime is required, and safety monitoring will continue throughout the study period. Total participation time can last up to two years with long-term follow-up opportunities.
CONDITIONS
Brief Title
A Study to Investigate the Efficacy of Pain Reduction With Cryoneurolysis Compared With Sham-treatment in Adults With Trigeminal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years or older at the time of signing informed consent
- Diagnosed with primary (classic or idiopathic) trigeminal neuralgia affecting mandibular and/or maxillary divisions, confirmed by a neurologist
- Able to classify trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition, with sufficient MRI evaluation
- History of at least three trigeminal neuralgia pain attacks per day on average in the last 4 weeks
- Average daily pain intensity (NRS score) between 4 and 10 in the last 4 weeks
- At baseline, average daily pain intensity (NRS score) between 4 and 10
- At baseline, average of at least three trigeminal neuralgia pain attacks per day
- Treatment resistant: failed or unable to tolerate carbamazepine or oxcarbazepine
- Stable preventive medication regimen for trigeminal neuralgia for at least 2 weeks before baseline and willing to keep it unchanged during the study
- Appropriate candidate for study intervention as judged by investigator
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Diagnosed with demyelinating inflammatory disorders such as multiple sclerosis
- Other pain conditions that could interfere with study procedures or pain reporting
- High risk of neurological deterioration due to other medical conditions
- High degree of comorbidity or frailty with reduced life expectancy or high hospitalization risk
- Medical conditions presenting excess procedural risk, including bleeding disorders
- Significant untreated addiction to medications, alcohol, or illicit drugs within 6 months
- Abnormal pain behavior, inappropriate medication use, or unresolved psychiatric illness affecting pain perception or compliance
- Previous procedures such as radiofrequency ablation, balloon compression, gamma knife, or chemical denervation of the trigeminal nerve or related ganglia
- Facial anomaly or trauma making the procedure difficult
- Active oral or dental infection at the injection site
- Major infectious processes or malignancies involving the face active or treated in past 6 months
- Current participation in another treatment study
- Sensory deficits or pain patterns suggesting trigeminal neuropathy rather than neuralgia
- Presence of conductive implants contraindicating nerve stimulation per study guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either cryoneurolysis or sham stimulation treatment to reduce trigeminal neuralgia pain.
1 treatment visit (in-person)
Duration - 4 weeks
Participants are monitored for pain reduction and safety outcomes after the intervention.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
St. Olavs University Hospital
Trondheim, Norway
Actively Recruiting
Research Team
I
Irina Aschehoug
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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