Multiple SclerosisMESO7NCT07202494
Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The MESO7 study is a prospective observational research project designed to investigate the mechanisms of resilience and neurodegeneration in neurological diseases and healthy aging. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
- What is being tested?
- Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging)
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2025to 18 May 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes 540 patients with various neurological diseases-multiple sclerosis (stratified by disability level), NMOSD/MOGAD, Alzheimer's disease, Parkinson's disease, ALS, epilepsy (temporal and non-temporal), and mild traumatic brain injury-and 160 healthy volunteers aged 18 to 90 years, evenly distributed by sex and age decade. All participants must provide informed consent, be free of major MRI contraindications, and have no uncontrolled somatic or psychiatric conditions. A subset of participants, including those with progressive conditions and healthy aging individuals, will undergo longitudinal follow-up at 1 and 2 years. The study aims to explore structural, functional, and metabolic brain changes across the lifespan and disease spectrum using ultra-high field MRI.
Who may be able to join
- Age:Female or male, aged 18 years or older.
- Health Status: 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.
- MRI Compatibility: No contraindications for MRI exams (e.g., claustrophobia, metal foreign bodies, pacemakers, severe kidney failure).
- Social Security Coverage: Participants must have social security coverage.
- Informed Consent: The participant must have read, understood, and signed the informed consent after being adequately informed about the study.
- Specific Disease Criteria (For Disease Groups): Specific inclusion criteria apply to each pathology, such as MS (based on McDonald criteria), NMOSD (Wingerchuk 2015), Alzheimer's (meeting NINCDS-ADRDA criteria), etc.
Who cannot join
- Pregnancy: Pregnant women are excluded from the study.
- Inability to Provide Informed Consent:
- Any participant who refuses to sign the informed consent or is unable to do so due to mental or physical conditions.
- Refusal of MRI: Individuals who refuse to undergo brain MRI.
- Contraindications for MRI:Participants with contraindications for MRI exams, such as claustrophobia, metal foreign bodies, pacemakers, or severe kidney failure.
- Medical Conditions: Known allergy to Dotarem (contrast agent) for neuroinflammatory patients. Individuals with severe renal insufficiency or other conditions that prevent MRI scanning.
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- Cognitive or Psychiatric Issues:
- Chronic psychiatric conditions, including severe dementia or cognitive dysfunction that could hinder participation.
- Legal or Institutional Restrictions:
- Adults under legal protection (e.g., under guardianship or curatorship). Individuals deprived of their liberty.
- Other Medical Conditions:
- Individuals with neurological diseases such as ischemic accidents, brain trauma, or encephalitis.
- Patients on treatments that would interfere with the study, as outlined for each disease.
- Allergy to Contrast Agent:
- Allergy to Dotarem for neuroinflammatory patients (MS, NMOSD, etc.).
- Inability to Adhere to Protocol:
- Participants who are unable or unwilling to comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), Alzheimer Disease, Parkinson Disease, Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging)
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Alzheimer Disease, Parkinson Disease, Amyotrophic Lateral Sclerosis, Epilepsy, Temporal Lobe, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging)Other
Functional MRI (fMRI) Diffusion Tensor Imaging (DTI) Sodium Imaging (23Na-MRI) Phosphorus Imaging (31P-MRI)
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | (160 participants, split by age and sex) Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Multiple Sclerosis | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Neuromyelitis Optica Spectrum Disorder (NMOSD) | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD) | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Alzheimer's Disease | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Parkinson's Disease | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Amyotrophic Lateral Sclerosis (ALS) | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Temporal Epilepsy | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Non-Temporal Epilepsy | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) | |
| Mild Traumatic Brain Injury (mTBI) | Not described Receives: Other: Imaging Techniques (MRI 3T & 7T, Functional, Structural, and Metabolic Imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodal Connectivity measured by resting-state BOLD fMRI and diffusion MRI tractography (graph-theoretical metrics)
Nodal connectivity will be assessed using graph-theoretical measures (in-degree, out-degree, and strength).
Measured: Baseline and 24 months (longitudinal follow-up)
Sodium Concentration as Indicators of Neuronal Energy Failure
Measured: Baseline and 24 months (longitudinal follow-up)
Secondary outcomes (5)
Regional sodium concentration and phosphorus metabolism in brain and spinal cord measured by 23Na-MRI and 31P-MRI
Metabolic changes will be quantified from quantitative 23Na-MRI (sodium concentration, indicator of neuronal energy failure) and 31P-MRI (phosphorus metabolism, indicator of energy consumption).
Measured: Baseline and 24 months (longitudinal follow-up)
Network Metrics
number of significant connections per node (in/out) and sum of edge weights per node (based on FA values).
Measured: Baseline and 24 months (longitudinal follow-up)
distance between the gray matter-white matter boundary and the pial surface (outer cortical surface). (Cortical Thickness)
distance between the gray matter-white matter boundary and the pial surface (outer cortical surface).
Measured: Baseline and 24 months (longitudinal follow-up)
Iron Accumulation (Concentration) in Cortical Layers
Iron accumulation is inferred from increased susceptibility values in specific laminar regions.
Measured: Baseline and 24 months (longitudinal follow-up)
Cortical thickness measured by structural MRI (MP2RAGE) and processed with FreeSurfer
Structural changes in brain gray matter will be assessed through quantitative cortical thickness measurements.
Measured: Baseline and 24 months (longitudinal follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start19 May 2025
- Primary completion18 May 2030 (estimated)
- Study completion18 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study chair, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202494
- Sponsor's protocol ID
- RCAPHM23_0203
- Acronym
- MESO7
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No