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NCT Number: NCT07477821

A Muscle-brain Interplay Study in Neurological Disorders

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.

Recruiting

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Key information

Conditions

Neurological Disorders Health Adult Subjects Nervous System Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universita degli Studi di Catania, Catania, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Good aging group:

Subjects aged 60 years or older
Frailty Index below the pathological cut-off (>0.25)
Absence of general cognitive impairment (MMSE > 24 points)
Absence of a diagnosis of sarcopenia

for Bad aging group:

Patients aged over 60 years
Exclusive presence of one of the following diagnoses:

Definite, probable, or probable laboratory-supported Amyotrophic Lateral Sclerosis (ALS), either sporadic or familial, according to the revised El Escorial Criteria for ALS diagnosis.
Parkinson's disease (PD) according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., Mov Disord., 2015 Oct; 30(12): 1591-1601).
Alzheimer's disease (AD), possible or probable, according to international diagnostic guidelines.
Diagnosis of severe acquired brain injury according to the Italian Guidelines for the Care of Patients in Vegetative State and Minimally Conscious State 2011 (approved by the Unified Conference on May 5, 2011 - Ministry of Health, Italy), with the presence of Sarcopenia.
Presence of Mild Cognitive Impairment (MCI), subjective memory complaint, or deficit in a single cognitive domain, according to international criteria and in absence of established neurological diseases and sarcopenia.
Presence of Sarcopenia as defined by the EWGSOP2 Sarcopenia Consensus, in the absence of cognitive deficits and established neurological diseases.

Exclusion criteria

Inability to provide informed consent.
Presence of severe and/or acute comorbidities (e.g., uncontrolled diabetes, heart failure, or a diagnosis of oncological disease), as determined by the research team.
Evidence of other previous neurological or psychiatric disorders involving the cognitive domain.
Uncontrolled or complicated systemic diseases or history of traumatic brain injury.
For subjects with Alzheimer's disease (AD), Parkinson's disease (PD), and Amyotrophic Lateral Sclerosis (ALS), individuals with a history of epilepsy will also be excluded.

Treatment and study plan

Primary outcomes

Change from baseline in The Edmonton Frail Scale (EFS)

Time frame: At baseline and T1 (6 months)

The EFS is one of just a few frailty assessment tools that capture multidimensional aspects of frailty. The EFS is used to flag more specific issues that warrant closer attention and follow up. In this way, healthcare providers can use frailty information to create an individualized care plan to be discussed with the person who has been assessed.

Study contacts

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

Christian Lunetta, MD

CONTACT

[email protected]

+39 0250725266

Davide Sattin, PsyD, PhD

CONTACT

[email protected]

+390250725246

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

IRCCS Centro Neurolesi Bonino Pulejo
University of Catania
University of Roma La Sapienza

Registry information

Official study title

A Translational Approach to Characterize the Muscle-brain Interplay in Neurological Non-communicable Diseases. The M-Brain Project

Acronym: M-Brain

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Mar 17, 2026
Registry last updated: Mar 17, 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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