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

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 themandibular and/or maxillary division, verified by a neurologist

3. Ability to subclassify the trigeminal neuralgia according to the The InternationalClassification of Headache Disorders, 3rd edition, i.e. sufficient magneticresonance (MR) evaluation is mandatory

4. History of minimum mean of three trigeminal neuralgia related pain paroxysms per daylast 4 weeks

5. History of minimum average daily pain intensity NRS score (ADP) of 4 to10 last 4weeks

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 perday

8. Treatment refractory as defined in this study as failure to respond, pending anadequate trial in the opinion of the investigator, contraindications or intractableside effect to one of two medications:

9. Carbamazepine

10. Oxcarbazepine

11. Unaltered prophylactic TN medication regime 2 weeks prior to baseline, and bewilling to keep regime unaltered during the baseline and the blinded study period.

12. Be an appropriate candidate for the study intervention required in this study on thebasis of the clinical judgment of the investigator

13. Capable of giving signed informed consent as which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.

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 opinionof 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, thatin the opinion of the investigator may confound outcome assessment.

4. Patients exhibiting a high degree of comorbidity and/or frailty associated withreduced life expectancy or high likelihood of hospitalization, at the discretion ofthe investigator.

5. Other coexisting current medical conditions, including, but not limited to, bleedingdiathesis and thrombophilia, that presents excess procedural risk, in the opinion ofthe 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 psychiatricillness, that in the opinion of the investigator are significant enough to impactperception of pain, compliance with intervention and/or ability to evaluatetreatment outcome.

8. Subject has had previous radiofrequency ablation (including non-lesional pulsedradiofrequency), 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 pulsedradiofrequency), balloon compression, gamma knife, or chemical denervation (e.g.glycerol treatments) of a division or branch of the trigeminal nerve being targetedin 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 thesite of injection based on present symptoms.

12. Subject has been diagnosed with any major infectious processes such asosteomyelitis, or primary or secondary malignancies involving the face that havebeen 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 theneurologist, trigeminal neuropathy as more likely diagnosis.

15. Patients with any kind of conductive implant with contraindication for nervestimulation according to study innervation.