Application of Multiparametric Structural and Functional MRI in Unraveling the Substrates of Cognitive Impairment and Disability in Multiple Sclerosis (MS MRI)

October 19, 2024 updated by: Zhuo Wang
Multiple sclerosis (MS) is a disabling inflammatory demyelinating disease of the nervous system that predominantly affects white matter, because of its complicated pathogenesis, and overlapping clinical manifestations with other inflammatory demyelinating diseases diseases, which compromises clinical diagnosis and assessment for some patients at an early stage, leading to delayed treatment. Therefore, the development and validation of simple, non-invasive, accurate biomarkers becomes an urgent need. Neurite orientation dispersion and density imaging (NODDI) is an advanced diffusion model applied to quantify the extent of neurite destruction, allowing early assessment of the integrity of brain white matter microstructure. Many previous studies have shown that diffusion tensor imaging (DTI) can reflect the damage caused by MS, but it cannot accurately describe the true course of fiber bundles, such as curved and crossed fiber bundles. In addition, most of the studies are cross-sectional and lack of longitudinal follow-up. In this study, NODDI technique was used to investigate the damage pattern of white matter microstructural integrity in the early stage of multiple sclerosis for early diagnosis and differential diagnosis. In addition, to evaluate the relationship between NODDI parameters and clinical disability and cognitive impairment in MS, reveal the relationship between the pattern of white matter microstructural integrity damage and the severity of the disease to improve the understanding of the pathophysiological mechanisms of clinical disability and cognitive impairment, and provide potential therapeutic targets. To search for imaging biomarkers that can assess/predict disability progression and cognitive deterioration in patients with MS. Based on the above results, we can then propose a comprehensive and individualized model for the initial diagnosis, progression and clinical prognosis in patients with MS.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Multiple sclerosis (MS) is a disabling inflammatory demyelinating disease of the nervous system that predominantly affects white matter, because of its complicated pathogenesis, and overlapping clinical manifestations with other inflammatory demyelinating diseases diseases, which compromises clinical diagnosis and assessment for some patients at an early stage, leading to delayed treatment. Therefore, the development and validation of simple, non-invasive, accurate biomarkers becomes an urgent need. Neurite orientation dispersion and density imaging (NODDI) is an advanced diffusion model applied to quantify the extent of neurite destruction, allowing early assessment of the integrity of brain white matter microstructure. Many previous studies have shown that diffusion tensor imaging (DTI) can reflect the damage caused by MS, but it cannot accurately describe the true course of fiber bundles, such as curved and crossed fiber bundles. In addition, most of the studies are cross-sectional and lack of longitudinal follow-up. In this study, NODDI technique was used to investigate the damage pattern of white matter microstructural integrity in the early stage of multiple sclerosis for early diagnosis and differential diagnosis. In addition, to evaluate the relationship between NODDI parameters and clinical disability and cognitive impairment in MS, reveal the relationship between the pattern of white matter microstructural integrity damage and the severity of the disease to improve the understanding of the pathophysiological mechanisms of clinical disability and cognitive impairment, and provide potential therapeutic targets. To search for imaging biomarkers that can assess/predict disability progression and cognitive deterioration in patients with MS. Based on the above results, we can then propose a comprehensive and individualized model for the initial diagnosis, progression and clinical prognosis in patients with MS.

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Gansu
      • LanZhou, Gansu, China, 730030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

44 age- and sex-matched HCs without neurological and psychological symptoms or a history of neuropsychological disorders were also included in the study.

Description

Inclusion Criteria:

  • o be included, they had to be (1) right-handed, (2) ≥ 18 years old

Exclusion Criteria:

  • without neurological and psychological symptoms or a history of neuropsychological disorders were also included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
60 patients with RRMS and 44 age- and sex-matched healthy controls
A total of 104 participants, including 44 healthy controls (HCs) and 60 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) based on the 2017 revised McDonald criteria (Thompson AJ), were enrolled for this study. To be included, they had to be (1) right-handed, (2) ≥ 18 years old, (3) relapse- and steroid-free for at least 1 month before MRI acquisition, (4) conducting a stable disease-modifying treatment for at least 3 months. The exclusion criteria were as follows: (1) sleep disorder or taking medication for sleep, (2) a history of stroke, epilepsy, head trauma, and cerebral small vessel diseases, (3) neuropsychological or psychiatric disorders, (4) neuromyelitis optica spectrum disorders and myelin oligodendrocyte glycoprotein antibody-associated disease. 44 age- and sex-matched HCs without neurological and psychological symptoms or a history of neuropsychological disorders were also included in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DTI-ALPS CPV
Time Frame: one year
diffusion tensor image analysis along the perivascular space (DTI-ALPS) choroid plexus volume
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuo Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 20, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 19, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024A-1077
  • 21JR7RA438 (Other Identifier: Gansu Province Clinical Research Center for Functional and Molecular Imaging)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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