Actively Recruiting

Age: 16Years - 75Years
All Genders
Healthy Volunteers
ID04106830

Prospective Cohort Study of Clinical and Imaging Patterns of Neuroinflammation Diseases (CLUE)

Led by Beijing Tiantan Hospital · Updated on 2024-12-24

1000

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with neuroinflammatory and demyelination diseases such as neuromyelitis optica spectrum disorders (NMOSDs), multiple sclerosis (MS), and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). This observational study aims to understand structural and functional changes in the brain, spinal cord, and optic nerve, as well as the inflammatory environment, using advanced magnetic resonance imaging (MRI) technologies. The study evaluates how these changes relate to disease activity and long-term disability. Participants will undergo various MRI scans including double inversion recovery (DIR), diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM), and resting-state functional imaging using 3T MRI, along with T1WI, T2WI, FLAIR, and SWI sequences using 7T MRI. Scans will be done at the acute stage and during follow-ups at 1 month, 6 months, and 1 year. While the study does not restrict treatment methods, many patients receive high-dose intravenous steroid therapy during the acute stage and immunomodulatory therapies like Azathioprine, Mycophenolate Mofetil, or Rituximab during remission. Participants will be monitored through these scheduled MRI scans and clinical assessments including the Expanded Disability Status Scale (EDSS), Timed 25-foot Walk, and visual acuity tests. Researchers will measure brain and spinal cord structural changes and functional changes over time from baseline through follow-up visits. The study involves healthy individuals as controls and spans a follow-up period of one year, allowing detailed observation of disease progression and treatment effects in this group of patients.

CONDITIONS

Brief Title

Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)

Who Can Participate

Age: 16Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 16 and 75 years
  • Diagnosed with a neuroinflammatory or demyelination disease
  • Have available demographic and clinical data at the time of disease onset
  • Provided informed written consent, or assent with parental/legal representative consent if under 16 years
Not Eligible

You will not qualify if you...

  • Have any condition that prevents undergoing MRI
  • Currently enrolled in another clinical trial where the treatment is blinded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day (acute stage)

Participants undergo initial MRI scans of the brain, spinal cord, and optic nerve at the acute stage to assess structural and functional changes related to neuroinflammatory diseases.

1 visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants return for follow-up MRI scans and clinical assessments to monitor disease progression and changes in brain and spinal cord structure and function over time.

3 visits (at 1 month, 6 months, and 1 year after acute stage; in-person)

Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

Loading map...

Research Team

Y

Yaou Liu, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

Similar Trials

Functional Assessment of Balance and Gait and Correlation Wi...

Multiple Sclerosis

Actively Recruiting

2 locations

"Selfie" Videos: A Novel, Patient-centered, Comprehensive Ap...

Multiple Sclerosis

Actively Recruiting

1 location

3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal ...

Multiple Sclerosis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial