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

NCT07794137 — Not yet recruiting, 100 participants, Centre Hospitalier Universitaire de Nice

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

RegistryNCT07794137, acronym PREDIMAG
StatusNot yet recruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorCentre Hospitalier Universitaire de Nice (Other)
ConditionsAnti-MAG Neuropathy, Peripheral Nervous System Disease, Anti-Myelin-Associated Glycoprotein Antibodie
InterventionsElectroneuromyography (ENMG) and Terminal Latency Index (TLI) Assessment (Diagnostic test)
Datesstart 2026-09-01 (estimated), primary completion 2026-09-01 (estimated), completion 2026-12-31 (estimated), first posted 2026-08-31, last updated 2026-08-31
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Anti-MAG Neuropathy All trials for Peripheral Nervous System Disease All trials of Electroneuromyography (ENMG) and Terminal Latency Index (TLI) Assessment

-Summary

"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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+Arms and interventions

ArmTypeInterventionsDescription
Anti-myelin-associated glycoprotein (anti-MAG) neuropathyDiagnostic Test: Electroneuromyography (ENMG) and Terminal Latency Index (TLI) AssessmentThis 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 ent
  • 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

+Outcome measures

Primary outcomes

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

  • Predictive performance of TLI according to treatment strategy [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.
  • Correlation between TLI, anti-MAG antibody titer, and INCAT score evolution [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.
  • Optimal TLI threshold for predicting treatment response [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

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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.

+Locations (1)

FacilityCityCountryStatus
CHU de NiceNice, Alpes MaritimesFrance

+Investigators