Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Imaging Evaluation of Central Nervous Autoimmune Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822623
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

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
MS (Multiple Sclerosis) NMO Spectrum Disorder Diagnostic Test: MRI

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computer Aided Imaging Evaluation of Central Nervous System Autoimmune Diseases
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 1, 2022


Group/Cohort Intervention/treatment
MS Diagnostic Test: MRI
MRI examination

NMOSD Diagnostic Test: MRI
MRI examination

Control Diagnostic Test: MRI
MRI examination




Primary Outcome Measures :
  1. Results of MRI data analysis [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822623


Contacts
Layout table for location contacts
Contact: Xaoyu Han 18560081083 710804284@qq.com
Contact: Anning Li 18560080268 anningli00@163.com

Sponsors and Collaborators
Qilu Hospital of Shandong University
Layout table for additonal information
Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04822623    
Other Study ID Numbers: 2020SDUCRCC019
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Neuromyelitis Optica
Autoimmune Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases