Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy (EXCIMAG)

February 10, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service de Neurologie Hôpital Pellegrin
      • Créteil, France, 94000
        • Service de Neurologie Hôpital Henry Mondor
      • Lille, France, 59037
        • Département de Neurologie Hôpital Roger Salengro
      • Limoges, France
        • service de neurologie, CHU Limoges
      • Lyon, France, 69677
        • Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer
      • Nantes, France, 44093
        • Laboratoire des explorations fonctionnelles, Hôtel Dieu
      • Paris, France, 75019
        • Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
      • Saint-Etienne, France, 42055
        • Service de Neurologie CHU St Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients
Patients suffering from anti-MAG neuropathy
Other: QTRAC assessment
Computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve
Other: Clinical assessment of peripheral nerve function
Clinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QTRAC-measured refractority of the median nerve
Time Frame: Inclusion
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.
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (ESTIMATE)

June 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGN_2014-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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