Multiple SclerosisMS MRINCT06653283
Application of Multiparametric Structural and Functional MRI in Unraveling the Substrates of Cognitive Impairment and Disability in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Zhuo Wang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- o be included, they had to be (1) right-handed, (2) ≥ 18 years old
Who cannot join
- without neurological and psychological symptoms or a history of neuropsychological disorders were also included in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
MRI
Lanzhou, Gansu, 730030
Zhuo Wang, Doctor, 18142618122, 2892904774@qq.com
About this study
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.
Read the 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
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive Impairment
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
DTI-ALPS CPV
diffusion tensor image analysis along the perivascular space (DTI-ALPS) choroid plexus volume
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuo Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuo Wang, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653283
- Sponsor's protocol ID
- 2024A-1077
- Other IDs
- 21JR7RA438
- Acronym
- MS MRI
- Status last verified
- Jan 2024
- First submitted
- 19 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Multiparametric Structural and Functional MRI in Unraveling the Substrates of Cognitive Impairment and Disability in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06653283
- Acronym / sponsor ID
- MS MRI / 2024A-1077
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Zhuo WangUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- o be included, they had to be (1) right-handed, (2) ≥ 18 years old
Key exclusion criteria (1 listed)
- without neurological and psychological symptoms or a history of neuropsychological disorders were also included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DTI-ALPS CPV
Time frame: one year
diffusion tensor image analysis along the perivascular space (DTI-ALPS) choroid plexus volume
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Zhuo Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhuo wang (18142618122, 2892904774@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DTI-ALPS CPV (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.