Actively Recruiting

Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT07202494

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-10-01

700

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

The MESO7 study is a prospective observational research project designed to investigate the mechanisms of resilience and neurodegeneration in neurological diseases and healthy aging. It leverages advanced multiparametric brain and spinal cord imaging at high (3T) and ultra-high magnetic fields (7T) to assess structural, functional, metabolic, and mesoscale changes in the central nervous system (CNS). Particular emphasis is placed on sodium (23Na-MRI) and phosphorus (31P-MRI) imaging, along with layer-dependent brain connectivity analysis. The primary objective is to evaluate the impact of neuronal energy failure, measured via sodium concentration, on functional and structural reorganization in both healthy individuals and patients with various neurological conditions. Directed brain network models will be constructed from MRI data to quantify the connectivity strength (in- and out-degree) of cortical nodes. These connectivity metrics will be correlated with sodium concentrations to assess energy failure and its role in network reorganization. Longitudinal follow-up over two years is planned for subgroups with clinically progressive diseases. Secondary objectives include decoding metabolic, microstructural, and functional signatures of successful aging at the laminar level; characterizing disease-specific patterns of cortical and spinal microstructure associated with physical and cognitive dysfunction; describing longitudinal mesoscale and metabolic changes; and generating representative normative imaging datasets for the neuroscience community. The study plans to enroll a total of 540 patients across 9 neurological conditions:Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), MOG Antibody Disease (MOGAD), Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), temporal and non-temporal epilepsy, and mild traumatic brain injury (mTBI),in addition to 160 age- and sex-matched healthy controls, totaling 700 participants. Imaging and clinical assessments will be performed at the CEMEREM center at Timone University Hospital, AP-HM, Marseille, France. Each participant will undergo multiparametric brain and spinal cord MRI, including DTI, BOLD, MP2RAGE, SWI, quantitative sodium and phosphorus imaging, and functional assessments including neuropsychological testing, visual and motor function tests. Disease-specific assessments such as OCT, evoked potentials, and disability scores (e.g., EDSS for MS) will also be included when appropriate. The study is expected to improve understanding of CNS adaptation mechanisms and support the development of more accurate diagnostic and prognostic tools for neurodegenerative diseases

CONDITIONS

Official Title

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female or male aged 18 years or older
  • No uncontrolled general diseases such as cancer, autoimmune diseases, liver failure, severe or untreated high blood pressure, or severe rhythm disorders
  • No chronic psychiatric illnesses including severe dementia
  • No contraindications for MRI exams such as claustrophobia, metal foreign bodies, pacemakers, or severe kidney failure
  • Must have social security coverage
  • Must have read, understood, and signed the informed consent after being properly informed about the study
  • Specific disease inclusion criteria apply for patients with conditions like Multiple Sclerosis (based on McDonald criteria), Neuromyelitis Optica Spectrum Disorders, Alzheimer's disease (meeting NINCDS-ADRDA criteria), and others
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Individuals who refuse or are unable to provide informed consent due to mental or physical conditions
  • Persons refusing to undergo brain MRI
  • Contraindications for MRI exams such as claustrophobia, metal foreign bodies, pacemakers, or severe kidney failure
  • Known allergy to Dotarem contrast agent for neuroinflammatory patients
  • Severe renal insufficiency or other conditions preventing MRI scanning
  • Chronic psychiatric conditions including severe dementia or cognitive dysfunction hindering participation
  • Adults under legal protection or deprived of liberty
  • Individuals with neurological diseases such as ischemic accidents, brain trauma, or encephalitis
  • Patients on treatments interfering with the study protocol
  • Allergy to Dotarem for neuroinflammatory patients
  • Participants unable or unwilling to comply with the study protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chu Timone

Marseille, France

Actively Recruiting

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Research Team

J

Jan-Patrick STELLMANN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

10

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