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NCT Number: NCT07794137

Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy

"Anti-myelin-associated glycoprotein (anti-MAG) neuropathy is a rare dysimmune peripheral neuropathy, most commonly associated with an IgM monoclonal gammopathy. Its course is generally slow but may lead to significant functional disability. Despite therapeutic advances, including rituximab, intravenous immunoglobulins (IVIg), immunochemotherapy, and more recently Bruton tyrosine kinase inhibitors (BTKi), treatment response remains highly variable between patients. The Terminal Latency Index (TLI), an electrophysiological parameter reflecting distal demyelination, is a recognized diagnostic marker of anti-MAG neuropathy. However, its potential role as a predictive biomarker of treatment response remains insufficiently studied. Identifying a simple, reproducible, and readily available biomarker that could predict treatment response would be of major clinical importance for personalized patient management and optimization of therapeutic strategies. This monocentric retrospective study will analyze clinical, biological, and electrophysiological data from patients with anti-MAG neuropathy followed at Nice University Hospital (CHU de Nice) to assess the predictive value of baseline TLI for clinical response 12 months after treatment initiation."

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Key information

Conditions

Anti-MAG Neuropathy Anti-Myelin-Associated Glycoprotein Antibodie Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Disease Peripheral Nervous System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroneuromyography (ENMG) and Terminal Latency Index (TLI) Assessment

Diagnostic Test

This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice). No additional intervention or modification of routine clinical care will be performed. Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives. Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula. The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed. Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded. No treatment will be assigned or modified by the study. Data will be pseudonymized and ente

Primary outcomes

  1. Favorable Clinical Response at 12 Months (≥1-Point Decrease in INCAT Score)

    Time frame: 12 months after treatment initiation

    Clinical response at 12 months, defined as a reduction of at least 1 point in the INCAT disability score from baseline. This outcome will be used to assess the predictive value of the baseline Terminal Latency Index (TLI) for treatment response in patients with anti-MAG neuropathy.

Secondary outcomes

  1. Predictive performance of TLI according to treatment strategy

    Time frame: 12 months after treatment initiation.

    Assessment of the predictive performance of baseline TLI for clinical response at 12 months, stratified according to the treatment strategy received.

  2. Correlation between TLI, anti-MAG antibody titer, and INCAT score evolution

    Time frame: Baseline to 12 months after treatment initiation

    Assessment of the association between baseline TLI, quantitative anti-MAG antibody titer, and change in the INCAT disability score from baseline to 12 months.

  3. Optimal TLI threshold for predicting treatment response

    Time frame: Baseline to 12 months after treatment initiation

    Determination of the optimal baseline TLI threshold for predicting clinical response at 12 months using Receiver Operating Characteristic (ROC) curve analysis and the Youden index

Study contacts

Contact information is provided by the study sponsor or research team.

Abderhmane Slioui

CONTACT

[email protected]

0492038953 ext. +33

Mecheli Cavalli

CONTACT

[email protected]

0492035435 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

A Monocentric Retrospective Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy

Acronym: PREDIMAG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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