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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT02468596

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)	Other: QTRAC assessment Other: Clinical assessment of peripheral nerve function	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

QTRAC-measured refractority of the median nerve [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Service de Neurologie Hôpital Pellegrin	Bordeaux	France	33076
2	Service de Neurologie Hôpital Henry Mondor	Créteil	France	94000
3	Département de Neurologie Hôpital Roger Salengro	Lille	France	59037
4	service de neurologie, CHU Limoges	Limoges	France
5	Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer	Lyon	France	69677
6	Laboratoire des explorations fonctionnelles, Hôtel Dieu	Nantes	France	44093
7	Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild	Paris	France	75019
8	Service de Neurologie CHU St Etienne	Saint-Etienne	France	42055