Neuralgia Arnold Clinical Trial
— CRYOARNOLDOfficial title:
Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study
| Verified date | March 2020 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | March 24, 2020 |
| Est. primary completion date | March 24, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient aged 18 and over - Patient with cephalalgic syndrome> 3 months, - Patient with an indication of first cryoneurolysis - Unilateral character of cephalalgic syndrome - Failure of oral treatment of stage II - Positive response (> 50% efficacy on pain EVA) to infiltration of Arnold's nerve - Subject having signed his written participation consent Exclusion Criteria: - Coagulation disorder - Infection in progress - Patient under anticoagulant - Contraindication to performing an MRI: 1. Any subject with a vascular stent implanted less than 6 weeks before the examination. 2. Any subject with implanted biomedical material deemed "unsafe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp. 3. Any acquisition procedure that does not meet the conditions required for "conditional" use in a subject carrying implanted biomedical material deemed "conditional" in the list: http://www.mrisafety.com/TheList_search.asp. 4. Any subject carrying an intra-ocular or intra-cranial ferromagnetic foreign body close to the nerve structures. 5. Any subject carrying a biomedical material such as a cardiac, neuronal or sensory stimulator (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained to perform MRI in these subjects. 6. Non-cooperating subject |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Grenoble-Alpes | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Morphological effect of Arnold's nerve cryoneurolysis | Visualization of Arnold's nerve after tracer cryoneurolysis by MRI | one month | |
| Secondary | analgesic efficacy of the cryoneurolysis of Arnold's nerve :Measure of pain with a numeric pain scale between 0 (no pain) to 10 (intolerable) | Measure of pain with a numeric pain scale between 0 (no pain) to 10 (intolerable) | day 7, one month, 3 months, 6 months, 12 months | |
| Secondary | Functional Impact of Pain-Related Disability After Cryoneurolysis by the Pain Disability Index Scale | Score in Pain Disability Index Scale. This scale measure the interference of pain on daily activities. There are 7 items with score range from 0 (no disability) to 10 (maximum disability) | day 7, one month, 3 months, 6 months, 12 months |