Imaging Evaluation of Central Nervous Autoimmune Diseases

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04822623
Collaborator
(none)
300
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Computer Aided Imaging Evaluation of Central Nervous System Autoimmune Diseases
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
MS

Diagnostic Test: MRI
MRI examination

NMOSD

Diagnostic Test: MRI
MRI examination

Control

Diagnostic Test: MRI
MRI examination

Outcome Measures

Primary Outcome Measures

  1. Results of MRI data analysis [2021-03-01-2022-06-30]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. 18-65 years old;

  2. 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;

  3. 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;

  4. MRI examination was complete: baseline, 6 months, 1 year, 2 years;

  5. Sign informed consent.

Exclusion Criteria:
  1. The course of disease was more than 30 years;

  2. History of brain injury or spinal cord injury;

  3. History of central nervous system infection or immunodeficiency syndrome;

  4. HBV, HCV patients, syphilis, HIV-1, HIV-2 patients;

  5. Suffering from mental illness;

  6. Pregnant and lactating women or patients planning to conceive within one year;

  7. Unable to cooperate to complete the follow-up due to geographical or other reasons;

  8. Patients also participated in other randomized controlled trials.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT04822623
Other Study ID Numbers:
  • 2020SDUCRCC019
First Posted:
Mar 30, 2021
Last Update Posted:
Mar 30, 2021
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2021