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

NCT ID: NCT02468596

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Patients suffering from anti-MAG neuropathy

Group Type EXPERIMENTAL

QTRAC assessment

Intervention Type OTHER

Computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve

Clinical assessment of peripheral nerve function

Intervention Type OTHER

Clinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale

Interventions

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QTRAC assessment

Computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve

Intervention Type OTHER

Clinical assessment of peripheral nerve function

Clinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Neurologie Hôpital Pellegrin

Bordeaux, , France

Site Status

Service de Neurologie Hôpital Henry Mondor

Créteil, , France

Site Status

Département de Neurologie Hôpital Roger Salengro

Lille, , France

Site Status

service de neurologie, CHU Limoges

Limoges, , France

Site Status

Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer

Lyon, , France

Site Status

Laboratoire des explorations fonctionnelles, Hôtel Dieu

Nantes, , France

Site Status

Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Service de Neurologie CHU St Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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AGN_2014-20

Identifier Type: -

Identifier Source: org_study_id

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