TerminatedNot Applicable

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

Stopped: lack of recruitment

France6 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

QTRAC-measured refractority of the median nerve

Timeframe: Inclusion

Trial details

NCT IDNCT02468596

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2019-11

View on ClinicalTrials.gov More Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy) trials