NCT04822623

Brief Summary

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system and the most common cause of non traumatic disability in young and middle-aged people. Neuromyelitis optica spectrum disease (nmosd) is an independent disease different from Ms. the pathogenesis and the mode of brain and spinal cord injury are different from MS, and the prognosis and optimal treatment are different. It is difficult to distinguish the two diseases in the early stage. Early diagnosis and treatment of the two diseases can greatly improve the quality of life of patients. Therefore, it is an urgent problem to clarify the difference between MS and nmosd injury patterns and to find sensitive imaging markers for early clinical intervention. With the continuous progress of computer aided diagnosis (CAD), it is more and more widely used in medicine, which is expected to help solve the above problems. The purpose of this study is to create a neuroimmune disease evaluation database based on image data. By combining brain and spinal cord imaging, and based on Zhang quantum space learning computer-aided technology, we can achieve accurate segmentation of MS and nmosd brain and spinal cord lesions, analyze the evolution characteristics of the disease at different time points, and screen the imaging indexes related to clinical scores combined with clinical and laboratory indexes Objective: to determine the different prognosis and its influencing factors at the clinical, imaging and molecular levels, and establish the model for predicting disease progression and prognosis, so as to provide the basis for early identification and assistance in guiding treatment and judging prognosis. Clinical information was collected: age, gender, course of disease, MMSE, EDSS disability score, nine hole test, 25 foot walking test. Assess the patient's information processing ability. Blood samples were collected. Imaging examination was performed. The patients were followed up regularly.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 30, 2021

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

March 11, 2021

Last Update Submit

March 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Results of MRI data analysis

    The baseline data of MS, nmosd and normal group were complete, and the number of cases completed follow-up according to the requirements reached the expected requirements (100 cases each), and met the statistical standards.

    2021-03-01-2022-06-30

Study Arms (3)

MS

Diagnostic Test: MRI

NMOSD

Diagnostic Test: MRI

Control

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

MRI examination

ControlMSNMOSD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients in MS group and nmosd group were recruited from the Department of Neurology (outpatient and inpatient); the volunteers in control group were recruited through subject recruitment advertisement.

You may qualify if:

  • years old;
  • Nmosd was diagnosed according to wingerchuk standard revised in 2015, MS was diagnosed according to McDonald standard revised in 2017, and 100 normal people were diagnosed;
  • In the acute stage, within 1 month of the onset or stable stage, there was no GD enhanced lesion on MRI, and EDSS score had no significant change within 6 months, which was more than 1 month from the last attack;
  • MRI examination was complete: baseline, 6 months, 1 year, 2 years;
  • Sign informed consent.

You may not qualify if:

  • The course of disease was more than 30 years;
  • History of brain injury or spinal cord injury;
  • History of central nervous system infection or immunodeficiency syndrome;
  • HBV, HCV patients, syphilis, HIV-1, HIV-2 patients;
  • Suffering from mental illness;
  • Pregnant and lactating women or patients planning to conceive within one year;
  • Unable to cooperate to complete the follow-up due to geographical or other reasons;
  • Patients also participated in other randomized controlled trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisNeuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMyelitis, TransverseOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 30, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2021

Study Completion

July 1, 2022

Last Updated

March 30, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share