Muscle–brain connections in older adults with and without neurological disorders

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

See if muscle–brain connections differ between healthy adults aged 60+ and people over 60 who have neurological disorders such as ALS, Parkinson's, Alzheimer's, or severe acquired brain injury.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Istituti Clinici Scientifici Maugeri SpA (other)
• Locations: 4 sites (Catania and 3 other locations)
• Trial ID: NCT07477821 on ClinicalTrials.gov

What this trial studies

This observational study compares two groups of people aged 60 and older: a "good aging" group (low frailty, no general cognitive impairment, no sarcopenia) and a group with defined neurological disorders (ALS, Parkinson's disease, Alzheimer's disease, or severe acquired brain injury). Participants undergo clinical evaluations including frailty and cognitive testing together with neuromuscular assessments to characterize muscle–nerve function and the neuromuscular junction. The goal is to link clinical measures and neuromuscular findings to patterns associated with healthy aging versus neurodegeneration. Data are collected at multiple Italian centers to build a comparative picture of the muscle–brain axis in aging.

Who should consider this trial

Good fit: Ideal participants are adults aged 60 or older who either meet the 'good aging' criteria (frailty index <0.25, MMSE >24, no sarcopenia) or have a confirmed diagnosis of ALS, Parkinson's disease, Alzheimer's disease, or severe acquired brain injury.

Not a fit: People under 60, those with marked frailty, general cognitive impairment (MMSE ≤24), sarcopenia, or neurological conditions not listed are unlikely to match the study groups or gain direct benefit.

Why it matters

Potential benefit: If successful, the findings could help identify early markers of neurodegeneration and inform ways to protect muscle–nerve function in older adults.

How similar studies have performed: Previous studies have suggested links between muscle function, neuromuscular junction changes, and neurodegeneration, but results are mixed and the muscle–brain axis remains an emerging field.

Eligibility criteria

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:

  1. Definite, probable, or probable laboratory-supported Amyotrophic Lateral Sclerosis (ALS), either sporadic or familial, according to the revised El Escorial Criteria for ALS diagnosis.
  2. 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).
  3. Alzheimer's disease (AD), possible or probable, according to international diagnostic guidelines.
  4. 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.
  5. 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.
  6. 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.

Where this trial is running

Catania and 3 other locations

• Universita degli Studi di Catania — Catania, Italy (ACTIVE_NOT_RECRUITING)
• IRCCS Centro Neurolesi Bonino Pulejo — Messina, Italy (RECRUITING)
• Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute — Milan, Italy (RECRUITING)
• University of Roma La Sapienza — Roma, Italy (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Christian Lunetta, MD

Conditions: Neurological Disorders, Health Adult Subjects, muscle, brain, aging, Neuromuscolar