Clinical trial NCT02468596: Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy
Official title: Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)
Keywords: Axonal excitability
Neuropathy
QTRAC
anti-MAG
Electrophysiology
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: QTRAC-measured refractority of the median nerve
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Neurologie Hôpital Pellegrin
city: Créteil
country: France
facility: Service de Neurologie Hôpital Henry Mondor
city: Lille
country: France
facility: Département de Neurologie Hôpital Roger Salengro
city: Limoges
country: France
facility: service de neurologie, CHU Limoges
city: Lyon
country: France
facility: Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer
city: Nantes
country: France
facility: Laboratoire des explorations fonctionnelles, Hôtel Dieu
city: Paris
country: France
facility: Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
city: Saint-Etienne
country: France
facility: Service de Neurologie CHU St Etienne
Study officials:
References: