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A Muscle-brain Interplay Study in Neurological Disorders

NCT07477821 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-03-17

No results posted yet for this study

Summary

Despite the improvements in life expectancy, neurodegenerative diseases (NDGs) have become the most dreaded disorders of older people. Aged brains show characteristic changes that are linked to neurodegeneration raising the question of whether these hallmarks represent the harbingers of NDGs. Lifestyle factors including, in particular physical exercise, have given particular attention to factors associated to movement issue as ones of the major factors in modulating the risk of developing NDGs, emphasizing the interest in the muscle-brain axis. Indeed, one of the crucial systems severely affected in several neuromuscular diseases is the loss of effective connection between muscle and nerve, and the neuromuscular junction (NMJ) represents the critical region at the level of which the two entities communicate.

Even if controversy exists on whether pathological events beginning at the NMJ precede or follow loss of motor units, some recent data highlight as NGDs (e.g. Amyotrophic Lateral Sclerosis, Alzheimer's Disease, and Parkinson's Disease) and Aging share some common pathologic features such as the loss of fast-twich fiber, a decreased number of synaptic vesicles and sarcopenia giving evidence supports the notion that NMJ dismantlement can occur independently from motor neuron degeneration and may represent an early pathogenic signature of muscle-nerve communication defects.

The M-Brain project is an observational, analytical case-control study that will apply a new approach to interpret data underling the NMJ dismantlement in NDGs patients by comparing their clinical and biological information with data obtained from people who have had a so called "good aging" and those who have had a "bad aging".

The study will collect data useful to identify potential predisposing or risk factors for the subsequent development of a NDGs or able to predict the phenotype traiectories of selected pathologies with differerent movement levels. The combination of a muscular and neurological phenotyping and a biological characterization combining biomarkers, miRNA and extracellular vesicle (EV) assessments will allow to better identify the determinants of muscle-brain cross-talk that can then be used as potential indicators for the definition of critical morphological and functional components involved in aging and some NGDs. The project then will aim to identify phenotyope trajectories of patients giving particular attention to the brain-muscle axis and movement issues in order to provide information useful for future clinical strategies able to minimaze risk/predisponent Factors.

Conditions

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • Universita degli Studi di Catania

    collaborator OTHER

  • IRCCS Centro Neurolesi Bonino Pulejo

    collaborator OTHER

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2026-10-31
Completion
2027-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477821 on ClinicalTrials.gov