Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04106830
Other study ID # KY 2019-050-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2025

Study information

Verified date July 2022
Source Beijing Tiantan Hospital
Contact Yaou Liu, PhD
Phone +86 1059975396
Email yaouliu80@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

CLUE is a prospective study to determine structural and functional changes of brain and spinal cord, as well as the inflammatory environment in patients with neuroinflammatory and demyelination disease. Subjects will receive new magnetic resonance (MR) technics including double inversion recovery (DIR) imaging diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) and resting-state functional imaging and follow up for one year.


Description:

The study is an observational study of multi model imaging to determine structural and functional changes of brain and spinal cord, as well as the inflammatory environment in patients with neuroinflammatory and demyelination disease. Brain and spinal cord involvement are common in neuroinflammatory and demyelination disease including clinical isolated syndrome (CIS), multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSDs). The pathophysiology in neuroinflammatory disease involves the intensive autoimmune inflammatory response, resulting in demyelination and neuroaxonal injury and loss. Some cerebrospinal fluid (CSF) biomarkers have been reported to indicate the pathology and reflect disease activity especially during acute stage. But they couldn't directly reflect the macroscopic and microscopic neuroaxonal change in brain and spinal cord, which seem to be important determinants of long-term severe disability in chronic neuroinflammatory disease. Finally, new MRI techniques are the most reliable and non-invasive method to assess the structure and function of brain and spinal cord, plus to monitor disease activity in clinical practice. Double inversion recovery (DIR) imaging allows better detection of cortical and white matter lesion, which has highlighted the role in MS. Diffusion kurtosis imaging (DKI) which has been proposed to characterize the deviation of water diffusion in neural tissues from Gaussian diffusion, is promising to provide information of demyelination and subsequent inflammatory processes in brain or spinal cord. Quantitative susceptibility mapping (QSM) has enabled MRI of tissue magnetic susceptibility to advance from simple qualitative detection of hypointense blooming artifacts to precise quantitative measurement of spatial biodistributions. QSM better depicts spatial susceptibility patterns in MS lesions compared to phase-based imaging. Besides, resting-state functional imaging has the potential to map the intrinsic functional brain networks and to detect early functional brain changes in neuroinflammatory disease. This study will be a prospective cohort study of patients with neuroinflammatory and demyelination disease. Subjects will undertake MR scans at acute stage, and required follow-up visits after 1 moth, 6 months and one year. The MR scans is necessary at each visit. This study does not limit treatment methods. Patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. The HD-S treatment course referred to intravenous administration of 1 g of glucocorticoid daily for 3 consecutive days and continuous dose 240 mg reduction for 60mg oral administration. Immunomodulatory therapies are necessary for the remission stage. The treatment methods include: Azathioprine (start at 50 mg per day, add 50 mg per week to 2 mg/kg*d); Mycophenolate Mofetil (The initial dose was 0.25g bid, add 0.5g per week to 0.75g bid); and Rituximab (500 mg on the 1st day, the 15th day, then 500mg per half year).


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria: - 18-60 - 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 18 years. Exclusion Criteria: - Patients for whom MRI is contra-indicated - Patients included in an ongoing clinical trial where the product is blinded

Study Design


Intervention

Drug:
Intravenous steroid
This study does not limit treatment methods.patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. The HD-S treatment course referred to intravenous administration of 1 g of glucocorticoid daily for 3 consecutive days and continuous dose 240 mg reduction for 60mg oral administration. Immunomodulatory therapies are necessary for the remission stage. The treatment methods include: Azathioprine (start at 50 mg per day, add 50 mg per week to 2 mg/kg.d); Mycophenolate Mofetil (The initial dose was 0.25g bid, add 0.5g per week to 0.75g bid); and Rituximab (500 mg on the 1st day, the 15th day, then 500mg per half year).

Locations

Country Name City State
China Beijing Tiantan Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later
Primary 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. On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later
Primary 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 On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later
Secondary 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. On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later
Secondary 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. On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later
Secondary 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.
On admission to the hospital on day 1, on discharge 180 days later and on follow up 360 days later
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis