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Nerve signal test may forecast treatment success in rare nerve disease

NCT ID NCT07794137

Diagnosis Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

Anti-MAG neuropathy is a rare nerve condition that can cause disability, and treatments like rituximab or IVIg work differently for each person. Researchers are studying whether a simple nerve test, the Terminal Latency Index (TLI), can predict who will respond well to treatment. They will review medical records from 100 patients at a French hospital, looking at nerve test results and disability scores 12 months after starting therapy. If TLI proves reliable, it could help doctors choose the best treatment for each patient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Electroneuromyography (ENMG) and Terminal Latency Index (TLI) assessment
What this could lead to
If TLI predicts treatment response, doctors could tailor therapies for anti-MAG neuropathy, improving outcomes and reducing ineffective treatments.
What could go wrong
This is a retrospective observational study, so it can show associations but not prove cause. The results may not apply to all patients, and TLI might not reliably predict response in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

"Adult patients with documented anti-MAG activity-associated neuropathy, followed at the Reference Center for Rare Diseases of the Peripheral Nervous System at Nice University Hospital (CHU de Nice) between January 2005 and July 2025. Planned number of participants: 100 patients."

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented anti-MAG IgM polyneuropathy: positive anti-MAG antibodies, associated with an IgM monoclonal gammopathy, and a compatible clinical phenotype. * Complete and interpretable baseline ENMG assessment: an initial electroneuromyography (ENMG) examination allowing reliable calculation of the TLI in at least two motor nerves among the right median, ulnar, and common fibular nerves. * The examination must include the distal motor latency, proximal motor conduction velocity, and compound muscle action potential (CMAP). * Treatment with at least one established therapeutic strategy: treatment initiated at the center, including intravenous immunoglobulins (IVIg), rituximab, immunochemotherapy, Bruton tyrosine kinase inhibitors (BTKi), and/or symptomatic treatment. * Available functional clinical assessment: a documented INCAT disability score at two predefined time points: baseline (before treatment initiation) and 12 months (±2 months) after treatment initiation. * Consent to participate in the study. Exclusion Criteria: * Peripheral neuropathy associated with an IgM monoclonal gammopathy, with strictly negative anti-MAG antibody testing or no available anti-MAG antibody measurement. * Incomplete or uninterpretable ENMG data preventing accurate calculation of the TLI for the nerves of interest (median and ulnar nerves). * Absence of a formally documented INCAT score at baseline or within the 12-month assessment window.

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Conditions

The condition(s) this trial relates to.

peripheral nervous system disorder polyneuropathy associated with IgM monoclonal gammapathy with anti-MAG

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-mag neuropathy Anti-myelin-associated glycoprotein antibodie Peripheral nervous system disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Nice

    Nice, Alpes Maritimes, 06000, France

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