NCT07461896 Studying Nerve Function and Structure in Charcot-Marie-Tooth Disease, Anti-MAG Neuropathy and CIDP
| NCT ID | NCT07461896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Charcot-Marie-Tooth |
| Study Type | OBSERVATIONAL |
| Enrollment | 39 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 39 participants in total. It began in 2025-03-03 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The project aims to perform both conventional nerve-conduction studies and axonal-excitability assessments using the TRONDF protocol in patients with selected forms of Charcot-Marie-Tooth disease, with comparison to individuals affected by dysimmune, acquired neuropathies, specifically chronic inflammatory demyelinating polyneuropathy (CIDP) and anti-MAG-neuropathy. The study further includes the analysis of nerve fibers obtained from skin biopsy in patients with CMT, as well as ultrasound evaluation of nerves (from the wrist to the axilla) and of intrinsic hand muscles. Axonal-excitability techniques involve the delivery of two electrical stimuli to the nerve under investigation; both stimuli vary in intensity, whereas only the first, known as the conditioning stimulus, varies in duration. Changes in response amplitude are then measured as these stimulation parameters are systematically adjusted. Some preliminary studies have already suggested the effectiveness of this method in distinguishing CMT1A from certain forms of acquired demyelinating disease, including acute inflammatory demyelinating polyradiculoneuropathy (AIDP) and CIDP. Despite the promising results, only a limited number of studies have so far been conducted in humans and mice, and no comprehensive and systematic study has yet been carried out describing the changes in axonal excitability in the various CMT subtypes, either in humans or in mouse models.
Eligibility Criteria
Inclusion Criteria: 1. The subject is ≥ 18 years old. AND: 2. A genetically confirmed diagnosis of one of the several CMT subtypes (i.e., CMT1A, CMT1B, CMTX1, CMT2I/J, CMT4B, CMT4D and CMT4J) OR 3. A clinical diagnosis of either Chronic Inflammatory Demyelinating Polyneuropathy or anti-MAG polyneuropathy Exclusion Criteria: 1. Known neuropathy from another cause (e.g., diabetes, chronic renal insufficiency, medications, alcohol), including previous carpal tunnel syndrome surgery. 2. History of exposure to chemotherapeutic agents (e.g., bortezomib, vincristine, cisplatin, taxol, vedotin/auromycin-conjugated antibodies), or other medications (e.g., disulfuram, thalidomide, voriconizole, chronic colchicine use) that can cause neuropathy, active alcohol abuse. 3. History of cancer, other than skin cancer, within 5 years prior to enrollment. 4. Pregnancy or nursing. 5. Known systemic disease that predisposes to neuropathy. 6. Other central nervous system diseases.
Contact & Investigator
Davide Pareyson, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Neurologico Carlo Besta
Frequently Asked Questions
Who can join the NCT07461896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Charcot-Marie-Tooth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07461896 currently recruiting?
Yes, NCT07461896 is actively recruiting participants. Contact the research team at davide.pareyson@istituto-besta.it for enrollment information.
Where is the NCT07461896 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07461896 clinical trial?
NCT07461896 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The principal investigator is Davide Pareyson, MD at Fondazione IRCCS Istituto Neurologico Carlo Besta. The trial plans to enroll 39 participants.