Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-75
SponsorBeijing Tiantan Hospital
About this trial
CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI. In addition, participants will receive a one-time baseline examination including T1WI, T2WI, FLAIR, and SWI sequences on 7T MRI, as well as PET-MRI.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
16-75
Diagnosis of neuroinflammatory and demyelination disease
Availability of demographic and clinical data at the time disease onset
Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years.
Disqualifiers
Patients for whom MRI is contra-indicated
Patients included in an ongoing clinical trial where the product is blinded
Trial population
To reflect the daily practices, this study includes all patients with neuroinflammatory and demyelination disease at the beginning of the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intravenous steroid
DrugThis study does not limit treatment methods. During the acute stage, patients commonly receive high-dose intravenous methylprednisolone (1g daily for 3-5 days). For severe or refractory cases, plasma exchange (PLEX) or intravenous immunoglobulin (IVIG) may be added. For PACNS, cyclophosphamide is added to steroids as standard induction. During remission, immunomodulatory or immunosuppressive therapies vary by disease: for MS, DMTs such as ocrelizumab or natalizumab; for NMOSD, rituximab (500mg on day 1 and 15, then every 6 months), eculizumab, or satralizumab; for MOGAD, azathioprine, mycophenolate mofetil, or rituximab but only for relapsing patients; for PACNS, azathioprine or mycophenolate mofetil for 12-18 months after cyclophosphamide; for AE, rituximab or cyclophosphamide for refractory cases, with maintenance only for relapsing forms.
Treatment groups
1,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: NMOSD1 intervention
Group B: Multiple sclerosis(MS)1 intervention
Group C: MOGAD1 intervention
Group D: Healthy controls (HC)0 interventions
Group E: PACNS1 intervention
Group F: AE1 intervention
Trial outcomes
Primary outcomes
1
The brain structural change over time between the baseline MRI and the follow-up MRIs
To describe changes of lesions, grey matter and white matter in patients with neuroinflammatory and demyelination disease measured by DIR and QSM. The primary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of the lesions and brain volumes.
Time frame
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later2
The spinal cord change over time between the baseline MRI and the follow-up MRIs.
To describe changes of lesions and integrity of fiber bundle in spinal cord in neuroinflammatory and demyelination disease patients measured by DKI. The primary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of structural change in spinal cord.
Time frame
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later3
The functional change over time between the baseline MRI and the follow-up MRIs.
To describe brain functional changes in patients with neuroinflammatory and demyelination disease measured by resting-state functional imaging. The primary endpoint is the functional change over time between the baseline MRI and the follow-up MRIs
Time frame
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days laterSecondary outcomes
1
Change from Baseline Expanded Disability Status Scale （EDSS）/ Functional Systems （FS）
admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later.\] The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of subjects with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to Multiple sclerosis (MS). In addition, it also provides eight subscale measurements called Functional System (FS) scores.
Time frame
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later2
Timed 25-foot Walk
Timed 25-foot walking trials will be assessed on admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later. The Timed 25-Foot Walk test is a quantitative measure of lower extremity function. If required, the subject may use an appropriate assistive device to walk as quickly as he/she can from one end to the other end of a clearly marked, unobstructed, 25-foot course. Timing will begin when any part of the subject's foot crosses the tape. Timing will end when any part of the subject's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds. The task is immediately administered again (a maximum five-minute rest period is allowed between trials) by having the subject walk back the same distance. The average of the two values will be recorded.
Time frame
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later3
Mean change in visual acuity as assessed by Sloan 2.5% low contrast visual acuity chart.
admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later.\] Low Contrast Visual Acuity: Low-contrast Sloan letter charts are readily available and provide a practical, quantitative, and standardized assessment of visual function. Each chart consists of rows of black letters (decreasing in size from top to bottom) on a white background. For this trial, 2.5% low contrast visual acuity will be measured on days 1 and 5 during the steroid phase and completion after the plasma exchange phase. Charts will be read at a 2.5-meter distance by trained examiners in the hospital room with constant lighting.
Time frame
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days laterSponsors and contacts
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Source ClinicalTrials.gov