Actively Recruiting

Age: 60Years +
All Genders
Healthy Volunteers
ID07477821

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

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-03-17

150

Participants Needed

4

Research Sites

21 weeks

Total Duration

On this page

Sponsors

I

Istituti Clinici Scientifici Maugeri SpA

Lead Sponsor

U

University of Roma La Sapienza

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how muscle and brain interactions relate to neurodegenerative diseases (NDGs) such as Amyotrophic Lateral Sclerosis, Alzheimer's Disease, and Parkinson's Disease, as well as aging. The study explores whether changes at the neuromuscular junction, where muscle and nerve communicate, contribute to these conditions. It aims to identify factors that influence brain-muscle connections and how these may predict disease progression or aging outcomes. This observational case-control study includes two groups: a "Good Aging" group of adults aged 60 or older without muscle or neurological impairments, and a "Bad Aging" group with patients diagnosed with NDGs or severe acquired brain injury, some with sarcopenia or cognitive issues. Researchers will collect clinical and biological data, including biomarkers, microRNA, and extracellular vesicle analyses, to better understand the muscle-brain relationship and movement issues. Participants will undergo assessments including the Edmonton Frail Scale at the start and after six months to measure frailty changes. The study will gather neurological and muscular phenotyping data to track participants' health trajectories. The study spans from baseline to a 6-month follow-up, monitoring physical and cognitive function to inform future clinical strategies for minimizing risks linked to aging and neurological disorders.

CONDITIONS

Brief Title

A Muscle-brain Interplay Study in Neurological Disorders

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects aged 60 years or older
  • For Good Aging group: frailty index below 0.25, no general cognitive impairment (MMSE > 24), and no diagnosis of sarcopenia
  • For Bad Aging group: diagnosis of one of the following: ALS, Parkinson's disease, Alzheimer's disease, severe acquired brain injury with sarcopenia, mild cognitive impairment or single cognitive domain deficit without established neurological diseases and sarcopenia, or sarcopenia without cognitive deficits
Not Eligible

You will not qualify if you...

  • Inability to provide informed consent
  • Presence of severe or acute comorbidities such as uncontrolled diabetes, heart failure, or cancer
  • Previous neurological or psychiatric disorders affecting cognition
  • Uncontrolled or complicated systemic diseases or history of traumatic brain injury
  • History of epilepsy for participants with Alzheimer's disease, Parkinson's disease, or ALS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At baseline and 6 months

Participants undergo assessments to evaluate muscle and brain function, cognitive status, and frailty.

2 visits (in-person)

Long-term Monitoring

Duration - 6 months

Participants are observed over time to monitor changes in frailty and neurological status without any intervention.

Trial Site Locations

Total: 4 locations

1

Universita degli Studi di Catania

Catania, Italy, 95131

Active, Not Recruiting

2

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, 98123

Actively Recruiting

3

Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

Milan, Italy, 20138

Actively Recruiting

4

University of Roma La Sapienza

Roma, Italy, 00185

Active, Not Recruiting

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Research Team

C

Christian Lunetta, MD

D

Davide Sattin, PsyD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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