Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study
Keywords
Abstract
Dates
Last Verified: | 02/29/2020 |
First Submitted: | 10/24/2018 |
Estimated Enrollment Submitted: | 11/06/2018 |
First Posted: | 11/07/2018 |
Last Update Submitted: | 03/29/2020 |
Last Update Posted: | 03/31/2020 |
Actual Study Start Date: | 03/24/2019 |
Estimated Primary Completion Date: | 03/23/2020 |
Estimated Study Completion Date: | 03/23/2020 |
Condition or disease
Intervention/treatment
Other: neuralgic patients
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: neuralgic patients MRI experimentation | Other: neuralgic patients 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | 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 |
Outcome
Primary Outcome Measures
1. Morphological effect of Arnold's nerve cryoneurolysis [one month]
Secondary Outcome Measures
1. analgesic efficacy of the cryoneurolysis of Arnold's nerve :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]
2. Functional Impact of Pain-Related Disability After Cryoneurolysis by the Pain Disability Index Scale [day 7, one month, 3 months, 6 months, 12 months]