ClinicalTrials.gov record NCT06845644

Longitudinal Quantitative Neuromuscular MRI in Neuropathic Patients

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Longitudinal Quantitative Neuromuscular MRI Evaluation in Patients With Acquired and Hereditary Neuropathy

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study uses quantitative neuromuscular MRI and neuromuscular ultrasound to measure imaging biomarkers over one year in people with CMT1A, hereditary transthyretin amyloid neuropathy (ATTR-PN), or acquired demyelinating neuropathy. The study compares imaging measures at enrollment and again about 12 months later to track change. It also looks for correlations between imaging and clinical/electrophysiological scores.

What it is studying. The study is measuring how MRI biomarkers—including intramuscular fat fraction (FF), magnetization transfer ratio (MTR), proton density (PD), T2 relaxation time, and 3D muscle volume—and ultrasound-measured nerve diameter change over one year (nerve-diameter ultrasound is assessed specifically in the ATTR-PN group). It also tests whether those imaging changes correlate with clinical scales and electrophysiology results.

What the researchers hope to learn. To quantify annual change in intramuscular fat fraction and other MRI biomarkers in these neuropathies. To measure annual change in nerve diameter by ultrasound in ATTR-PN. To examine correlations between imaging biomarkers and clinical and electrophysiological scores to inform future clinical trials and monitoring tools.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The pathophysiological process common to neuropathies is fatty replacement of muscle tissue, more commonly known as intramuscular fat fraction (F.F). MRI is an imaging technique that enables us to distinguish between muscle and fat tissue, and thus to objectify in vivo structural changes within nerves and muscles in neuropathic patients. In addition to visualizing these changes, quantitative neuromuscular MRI (qMRI) can be used to quantify a number of biomarkers associated with these pathophysiological processes. Over the past few years, this procedure has become a relevant tool in a number of neuromuscular pathologies, such as acquired and hereditary neuropathies. Thanks to its non-ionizing nature and its ability to explore tissues in three dimensions, MRI is the technique of choice for evaluating these diseases, complementing the clinical and electrophysiological scores available. In a context where numerous therapic strategies are being evaluated for the treatment of peripheral nervous system diseases, the clinical and electrophysiological scores currently available are proving inadequate for the detection of early change or a positive therapeutic effect. On the basis of a limited number of studies, quantitative MRI could provide much more sensitive therapeutic monitoring data over short periods of time which is crucial for future therapeutic trials. The most interesting MRI biomarker to date would therefore be the FF, which represents the percentage of fatty infiltration of muscles following pathological nerve damage. Other MRI biomarkers, such as quantified magnetization transfer ratio (MTR), proton density (PD), water transverse relaxation time (wT2) and three-dimensional volume, enable us to study the degenerative and inflammatory phenomena at work in these neuropathies from different angles, detailing the nerve and muscle damage in patients compared with healthy controls or presymptomatic patients. In patients with Charcot-Marie-Tooth (CMT) neuropathy in particular, qMRI is the only tool to detect significant longitudinal variation over a one-year period, revealing an average increase in FF in the lower limbs of +1.5% over 12 months. Confirmation of these results and their extension to other neuropathies such as hereditary amyloid neuropathies (ATTR-PN) or acquired demyelinating neuropathies (ADN) is therefore justified, but requires the implementation of standardized longitudinal studies including these different pathologies. As strong correlations between these MRI biomarkers and the main clinical scores have been demonstrated in several cross-sectional studies, the clinical value of this non-invasive tool is beyond doubt. The main limitation to the clinical deployment of this technology remains the time required for the manual segmentation step to delineate the areas of interest. The ongoing development of new image analysis techniques, as well as the contribution of artificial intelligence and deep learning to the imaging data extraction process, are well on the way to solving this problem, but require continuous updating of practices to identify the most interesting MRI biomarkers, facilitate their extraction and thus measure their clinical application with a view to future therapeutic trials.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Quantitative neuromuscular MRI
  • Neuromuscular ultrasound

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Male or female between 18 and 80 years of age,
  • Patients who have freely given their consent to participate in this study,
  • Patient with genetically confirmed hereditary CMT neuropathy
  • or patient with an acquired demyelinating neuropathy such as typical PIDC or anti-MAG of typical form
  • or a patient with a genetically confirmed pathogenic mutation in the transthyretin (TTRn) gene,
  • Patients who are beneficiaries or entitled beneficiaries of a social security scheme.

Exclusion criteria

  • Patients with co-morbidity or a history of other peripheral neuropathy,
  • Patients with alcohol or psychoactive substance abuse,
  • Patients with contraindications to MRI exploration: claustrophobia, pacemakers, Holter systems, IUDs, metal surgical clips, metal prostheses or implants (or other metal foreign bodies),
  • Patient unable to perform the MRI due to severe handicap,
  • Patient in a period of exclusion from another research protocol at the time of signing the consent/non-opposition form,
  • Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),
  • Persons who cannot read and understand the French language well enough to be able to give their consent to participate in research.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have quantitative neuromuscular MRI scans at inclusion and again about one year later to measure muscle fat fraction and other MRI biomarkers; neuromuscular ultrasound (nerve-diameter measurement) is collected specifically for ATTR-PN patients. They will undergo clinical assessments (for example ONLS, MRC testing, 10‑meter walk and disease‑specific scores) and electrophysiological measurements (MUNIX). MRI and ultrasound are non‑invasive; electrophysiological testing may cause discomfort. The registry lists these imaging and clinical/electrophysiological assessments between inclusion and one year after.

How the study is structured. Interventional, non-randomized study with parallel groups by diagnosis. Participants undergo quantitative neuromuscular MRI at study entry and again about one year later; neuromuscular ultrasound (nerve-diameter measurement) is performed specifically in the ATTR-PN group. Imaging is not masked. Data are used to measure annual change in imaging biomarkers and to compare those changes with clinical and electrophysiological measurements.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
May 23, 2025
Primary completion
May 23, 2026 (estimated)
Study completion
May 2028 (estimated)
Target enrollment
120 participants (estimated)
Last updated on registry
May 31, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique Hopitaux De Marseille

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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