NCT03735914

Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

According to the World Health Organization (WHO), headaches are one of the most common nervous system disorders. The therapeutic strategy is well established for certain subcategories of headache. On the other hand, when headaches become refractory, some nerves may become the target of targeted therapies. This is the case of the Arnold nerve, also called the great occipital nerve, which is involved in certain pathologies, both physiopathologically and therapeutically. The Arnold nerve infiltration has a relatively short duration of effectiveness (about 1 month on average), some teams have reported the interest of achieving a destruction of the Arnold nerve by radio frequency, with extended durations of efficiencies to several months. The use of cryoneurolysis has been known for a long time and its effectiveness in the management of cranio-facial pain is already reported. It is thus possible to obtain, at the end of the cryoanalgesia needle, very low temperatures around -40 ° C, which leads to the formation of an ice cube and, where appropriate, the freezing of the structures (nerves among others) to the needle contacts. This induces the formation of microcrystals leading to irreversible lesions of vasa-nervorums resulting in an endoneural edema. In the long run, it appears a Wallerian degeneration without destruction of this endoneurum. This is associated with the lack of destruction of the structure of the Schwann cell. Nerve regeneration is possible. The diffusion MRI study allows tractographic reconstruction of the nerves. This is the only imaging technique that focuses on the fibrillar structure of the nerves, thus enabling the detection of nerves throughout its path. It is a morphological imaging technique nevertheless it also allows a quantitative analysis of the nerve through certain parameters. The Investigators hypothesize that the cryoneurolysis of the Arnold nerve will result in the disappearance of visualization of the nerve by MRI tractography. The effect of cryoneurolysis on Arnold nerves, as on other peripheral nerves through diffusion MRI has never been described. The follow-up of MRI patients who had undergone cryoneurolysis would make it possible to study the behavior of these nerves after cryoneurolysis, and to correlate the aspect in tractography with the clinical data. Painful recurrence can then be correlated with visualization of the nerves by MRI.

Conditions

• Neuralgia Arnold

Interventions

Type	Name	Description
OTHER	MRI	Neuralgic patients for which a cryoneurolysis has been indicated, will passed an MRI befor and after the cryoneurolysis to check the presence of the nerve.

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2018-11-08
• Last updated: 2020-04-01

Locations

1 site across 1 country: France