Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy (EXCIMAG)
Primary Purpose
Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QTRAC assessment
Clinical assessment of peripheral nerve function
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy) focused on measuring Axonal excitability, Neuropathy, QTRAC, anti-MAG, Electrophysiology
Eligibility Criteria
Inclusion Criteria:
- Anti-MAG neuropathy (peripheral neuropathy and IgM monoclonal gammopathy with anti-MAG activity superior to 1000 BTU)
Exclusion Criteria:
- current treatment with a medication that modifies peripheral nerve excitability (e.g. anticonvulsivants)
Sites / Locations
- Service de Neurologie Hôpital Pellegrin
- Service de Neurologie Hôpital Henry Mondor
- Département de Neurologie Hôpital Roger Salengro
- service de neurologie, CHU Limoges
- Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer
- Laboratoire des explorations fonctionnelles, Hôtel Dieu
- Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
- Service de Neurologie CHU St Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Patients suffering from anti-MAG neuropathy
Outcomes
Primary Outcome Measures
QTRAC-measured refractority of the median nerve
the duration of the refractory period of the median nerve (expressed in milliseconds) is automatically measured by the QTRAC system, using a series of double electrical stimulations (the first being supra-maximal and the second, sub-maximal) and progressively increasing the time between the two stimuli.
Secondary Outcome Measures
Full Information
NCT ID
NCT02468596
First Posted
March 3, 2015
Last Updated
February 10, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02468596
Brief Title
Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy
Acronym
EXCIMAG
Official Title
Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
February 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve.
Because of its high sensitivity to small changes in axonal excitability, QTRAC may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability is early affected in this disease.
The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with QTRAC results in healthy persons (matched for sex and age).
A secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the QTRAC and could be predicted by a model based on the several parameters measured in the QTRAC exploration.
100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological examination with clinical scoring. The results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the QTRAC software.
The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of QTRAC-measured parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)
Keywords
Axonal excitability, Neuropathy, QTRAC, anti-MAG, Electrophysiology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients suffering from anti-MAG neuropathy
Intervention Type
Other
Intervention Name(s)
QTRAC assessment
Intervention Description
Computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve
Intervention Type
Other
Intervention Name(s)
Clinical assessment of peripheral nerve function
Intervention Description
Clinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale
Primary Outcome Measure Information:
Title
QTRAC-measured refractority of the median nerve
Description
the duration of the refractory period of the median nerve (expressed in milliseconds) is automatically measured by the QTRAC system, using a series of double electrical stimulations (the first being supra-maximal and the second, sub-maximal) and progressively increasing the time between the two stimuli.
Time Frame
Inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anti-MAG neuropathy (peripheral neuropathy and IgM monoclonal gammopathy with anti-MAG activity superior to 1000 BTU)
Exclusion Criteria:
current treatment with a medication that modifies peripheral nerve excitability (e.g. anticonvulsivants)
Facility Information:
Facility Name
Service de Neurologie Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Neurologie Hôpital Henry Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Département de Neurologie Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
service de neurologie, CHU Limoges
City
Limoges
Country
France
Facility Name
Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer
City
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
Laboratoire des explorations fonctionnelles, Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Service de Neurologie CHU St Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Learn more about this trial
Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy
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