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Compares treatment options for Trigeminal Neuralgia
Official title A Study to Investigate the Efficacy of Pain Reduction With Cryoneurolysis Compared With Sham-treatment in Adults With Trigeminal Neuralgia
ClinicalTrials.gov ID: NCT06213155
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- High probability of neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome...
- Patients exhibiting a high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the...
- Other coexisting current medical conditions, including, but not limited to, bleeding diathesis and thrombophilia, that presents excess procedural...
- Have within 6 months of enrollment a significant untreated addiction to dependency- producing medications, alcohol, or illicit drugs.
See the full eligibility criteria
Who can 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
- 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.
What rules you out
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.