Clinical Trials Directory

Trials / Unknown

UnknownNCT06653283

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

Status
Unknown
Phase
Study type
Observational
Enrollment
104 (estimated)
Sponsor
Zhuo Wang · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2024-10-20
Primary completion
2025-10-30
Completion
2025-12-30
First posted
2024-10-22
Last updated
2024-10-22

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06653283. Inclusion in this directory is not an endorsement.