Trigeminal NeuralgiaCryoGemNCT06213155
A Study to Investigate the Efficacy of Pain Reduction With Cryoneurolysis Compared With Sham-treatment in Adults With Trigeminal Neuralgia
A study testing Cryoneurolysis and Stimulation in people with Trigeminal Neuralgia, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Cryoneurolysis and Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 29 Feb 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Diagnosed with demyelinating inflammatory disorders such as e.g. multiple sclerosis.
- 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.
- High probability of neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.
- 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.
- 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.
- Have within 6 months of enrollment a significant untreated addiction to dependency- producing medications, alcohol, or illicit drugs.
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- 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.
- 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.
- 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.
- Facial anomaly or trauma which renders the planned procedure difficult.
- Subject currently has an active oral or dental abscess or a local infection at the site of injection based on present symptoms.
- 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.
- Current participation in another treatment study
- Sensory deficits and/or pain configuration supporting, in the opinion of the neurologist, trigeminal neuropathy as more likely diagnosis.
- Patients with any kind of conductive implant with contraindication for nerve stimulation according to study innervation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Cryoneurolysis, Stimulation
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisDevice
Cryoneurolysis
StimulationDevice
Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis | Experimental | Not described Receives: Device: Cryoneurolysis |
| Stimulation | Sham comparator | Not described Receives: Device: Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily pain
Difference in number of treatment responders (≥ 75% reduction in the mean average daily pain intensity on a NRS score) at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline in the treatment versus the sham group.
Measured: Weeks 3 - 4 post-intervention compared to baseline
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of treatment-emergent adverse events and serious adverse events.
Measured: Week 1-4
Secondary outcomes (7)
50% responders
Difference in number of treatment responders (≥ 50% reduction in the mean average daily pain intensity on a Numeric Rating Scale (NRS) score at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline) in the treatment versus the sham group.
Measured: Weeks 3 - 4 post-intervention compared to baseline
100% responders
Difference in number of complete responders (100% reduction in the mean average daily pain intensity on a NRS score at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline) in the active arm versus the sham arm.
Measured: Weeks 3 - 4 post-intervention compared to baseline
Patient Global Impression of Change (PGI-C) scale responders (a PGI- C responder is defined as having a response of "much improved" or "very much improved" at week 4.)
Difference in number of PGI-C responders corresponding to the treated branch at week 4 in the active arm versus sham arm.
Measured: Week 4
Barrow Institute of (BNI- P) responders (a clinically significant response is defined as having BNI I - BNI IIIb at week 4).
Difference in number of clinically significant BNI-P responders at week 4 in the active arm versus sham arm.
Measured: Week 4 in the active arm versus sham arm.
Barrow Institute of (BNI- P) excellent responders (excellent response is defined as having BNI I - BNI II at week 4).
Difference in number of excellent BNI-P responders at week 4 in the active arm versus sham arm.
Measured: Weeks 3 - 4 post-intervention compared to baseline
Penn Facial Pain Scale- Revised (PENN-FPS-R) score.
Difference in reduction of PENN-FPS-R from baseline to week 4 in the active arm versus sham arm.
Measured: Week 4 post-intervention compared to baseline
Change in mean average daily pain intensity NRS score (ADP) in the active versus sham arm.
Difference in reduction mean average daily pain intensity NRS score (ADP) corresponding to the treated branch at weeks 3 - 4 compared to baseline in the active arm versus the sham arm.
Measured: Weeks 3 - 4 post-intervention compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start29 Feb 2024
- Primary completion8 Jan 2026
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213155
- Sponsor's protocol ID
- 630286
- Acronym
- CryoGem
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06213155
- Acronym / sponsor ID
- CryoGem / 630286
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis | Experimental | Device: Cryoneurolysis |
| Stimulation | Sham comparator | Device: Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- Diagnosed with demyelinating inflammatory disorders such as e.g. multiple sclerosis.
- 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.
- High probability of neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurolysisCryoneurolysis | Device | Cryoneurolysis |
| StimulationStimulation | Device | Stimulation |
Primary outcome
Average daily pain
Time frame: Weeks 3 - 4 post-intervention compared to baseline
Difference in number of treatment responders (≥ 75% reduction in the mean average daily pain intensity on a NRS score) at weeks 3 - 4 post-intervention for paroxysmal pain corresponding to the treated branch compared to baseline in the treatment versus the sham group.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Week 1-4
Occurrence of treatment-emergent adverse events and serious adverse events.
7 secondary outcomes
50% responders
Time frame: Weeks 3 - 4 post-intervention compared to baseline
100% responders
Time frame: Weeks 3 - 4 post-intervention compared to baseline
Patient Global Impression of Change (PGI-C) scale responders (a PGI- C responder is defined as having a response of "much improved" or "very much improved" at week 4.)
Time frame: Week 4
Barrow Institute of (BNI- P) responders (a clinically significant response is defined as having BNI I - BNI IIIb at week 4).
Time frame: Week 4 in the active arm versus sham arm.
Barrow Institute of (BNI- P) excellent responders (excellent response is defined as having BNI I - BNI II at week 4).
Time frame: Weeks 3 - 4 post-intervention compared to baseline
Penn Facial Pain Scale- Revised (PENN-FPS-R) score.
Time frame: Week 4 post-intervention compared to baseline
Change in mean average daily pain intensity NRS score (ADP) in the active versus sham arm.
Time frame: Weeks 3 - 4 post-intervention compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis and Stimulation in people with Trigeminal Neuralgia, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily pain (time frame: Weeks 3 - 4 post-intervention compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.