Can freezing a nerve silence the 'Suicide Disease'?
NCT ID NCT06213155
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial tests whether a freezing technique called cryoneurolysis can reduce the intense facial pain of trigeminal neuralgia, a condition often described as one of the most painful known. Adults with the condition will be randomly assigned to receive either the real freezing treatment or a sham (fake) procedure, and neither they nor their assessors will know which they got. The main goal is to see how many people experience at least a 75% reduction in daily pain over the first month after treatment. After that, all participants may receive the treatment as needed for up to two years, while safety and side effects are closely monitored.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cryoneurolysis (a freezing technique applied to a peripheral nerve)
- What this could lead to
- If effective, this freezing technique could offer a new, non-drug option for people with severe facial pain that hasn't responded to medication.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The procedure carries risks like numbness or nerve damage, and the sham comparison will test if benefits are real or due to placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Feb 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant must be 18 years at the time of signing the informed consent 2. A diagnosis of primary (classic and idiopathic) trigeminal neuralgia affecting the mandibular and/or maxillary division, verified by a neurologist 3. 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 4. History of minimum mean of three trigeminal neuralgia related pain paroxysms per day last 4 weeks 5. History of minimum average daily pain intensity NRS score (ADP) of 4 to10 last 4 weeks 6. In baseline minimum average daily pain intensity NRS score (ADP) of 4 to 10 7. In baseline minimum mean of three trigeminal neuralgia related pain paroxysms per day 8. 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: 1. Carbamazepine 2. Oxcarbazepine 9. 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. 10. Be an appropriate candidate for the study intervention required in this study on the basis of the clinical judgment of the investigator 11. 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. Exclusion Criteria: 1. Diagnosed with demyelinating inflammatory disorders such as e.g. multiple sclerosis. 2. 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. 3. High probability of neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment. 4. 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. 5. Other coexisting current medical conditions, including, but not limited to, bleeding diathesis and thrombophilia, that presents excess procedural risk, in the opinion of the investigator. 6. Have within 6 months of enrollment a significant untreated addiction to dependency- producing medications, alcohol, or illicit drugs. 7. Abnormal pain behavior, inappropriate medication use and/or unresolved psychiatric illness, that in the opinion of the investigator are significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome. 8. Subject has had previous radiofrequency ablation (including non-lesional pulsed radiofrequency), balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the Gasserian ganglion. 9. Subject has had previous radiofrequency ablation (including non-lesional pulsed radiofrequency), balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of a division or branch of the trigeminal nerve being targeted in this study. 10. Facial anomaly or trauma which renders the planned procedure difficult. 11. Subject currently has an active oral or dental abscess or a local infection at the site of injection based on present symptoms. 12. Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past 6 months. 13. Current participation in another treatment study 14. Sensory deficits and/or pain configuration supporting, in the opinion of the neurologist, trigeminal neuropathy as more likely diagnosis. 15. Patients with any kind of conductive implant with contraindication for nerve stimulation according to study innervation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Olavs University Hospital
Trondheim, Norway
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Laser showdown: which light therapy zaps facial pain best?
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- AI and VR join forces to fight severe facial pain