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

Primary Purpose

Neuralgia Arnold

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuralgia Arnold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble-Alpes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neuralgic patients

Arm Description

MRI experimentation

Outcomes

Primary Outcome Measures

Morphological effect of Arnold's nerve cryoneurolysis
Visualization of Arnold's nerve after tracer cryoneurolysis by MRI

Secondary Outcome Measures

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)
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)

Full Information

First Posted
October 25, 2018
Last Updated
March 30, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03735914
Brief Title
Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study
Acronym
CRYOARNOLD
Official Title
Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Inclusion period finished
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 24, 2020 (Actual)
Study Completion Date
March 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia Arnold

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neuralgic patients
Arm Type
Experimental
Arm Description
MRI experimentation
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphological effect of Arnold's nerve cryoneurolysis
Description
Visualization of Arnold's nerve after tracer cryoneurolysis by MRI
Time Frame
one month
Secondary Outcome Measure Information:
Title
analgesic efficacy of the cryoneurolysis of Arnold's nerve :Measure of pain with a numeric pain scale between 0 (no pain) to 10 (intolerable)
Description
Measure of pain with a numeric pain scale between 0 (no pain) to 10 (intolerable)
Time Frame
day 7, one month, 3 months, 6 months, 12 months
Title
Functional Impact of Pain-Related Disability After Cryoneurolysis by the Pain Disability Index Scale
Description
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)
Time Frame
day 7, one month, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Any subject with a vascular stent implanted less than 6 weeks before the examination. Any subject with implanted biomedical material deemed "unsafe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp. 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. Any subject carrying an intra-ocular or intra-cranial ferromagnetic foreign body close to the nerve structures. 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. Non-cooperating subject
Facility Information:
Facility Name
CHU Grenoble-Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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

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