Imaging Evaluation of Central Nervous Autoimmune Diseases

Computer Aided Imaging Evaluation of Central Nervous System Autoimmune Diseases

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.

Study Overview

• Status: Unknown
• Conditions: MS (Multiple Sclerosis); NMO Spectrum Disorder
• Intervention / Treatment: Diagnostic test: MRI

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Diagnostic test: MRI; MRI examination
MS	Diagnostic test: MRI; MRI examination
NMOSD	Diagnostic test: MRI; MRI examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 28, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 28, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Multiple Sclerosis; Neuromyelitis Optica; Autoimmune Diseases
• Other Study ID Numbers: 2020SDUCRCC019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No