We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)

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: NCT05415579
Recruitment Status : Not yet recruiting
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Ying Gao, Dongzhimen Hospital, Beijing

Brief Summary:
Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) is an observational study aiming to better define the multidimensional (epidemiologic, demographic and clinical) characteristics of Demyelinating Diseases of the Central Nervous System (DDC) patients receiving Traditional Chinese medicine (TCM) treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.

Condition or disease Intervention/treatment
Demyelinating Diseases of the Central Nervous System (DDC) Other: Traditional Chinese medicine (TCM)

Detailed Description:
Demyelinating Diseases of the Central Nervous System (DDC) is a collective term for a group of immune-mediated disorders including multiple sclerosis, Neuromyelitis optica spectrum disorder, and myelin oligodendrocyte glycoprotein associated disorder, characterized by myelin loss and axonal damage in the central nervous system. Traditional Chinese medicine (TCM), a main form of complementary and alternative medicine provides a potential possibility to DDC management and has been applied to a considerable number of patients with this disorder in China as well as in other regions or countries worldwide. Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) provides a prospective and voluntary registry aiming to include 2000 eligible adult DDC patients with TCM intervenes from around 30 participating centers by using a web-based system. Baseline data will be recorded and subsequently regular follow-up visits will be implemented every 3-6 months for a total of 5 years. Main objective of DATE-TCM is to create an organized multicenter structure to collect reliable data for better define the multidimensional (epidemiologic, demographic and clinical) characteristics of DDC patients receiving TCM treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
Estimated Study Start Date : June 20, 2022
Estimated Primary Completion Date : October 31, 2029
Estimated Study Completion Date : May 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Group/Cohort Intervention/treatment
DDC patients with Traditional Chinese medicine (TCM) treatment

TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.

This study does not limit Western medical treatment methods. Patients commonly applied high dose of intravenous steroid treatment in the acute phase, which usually referred to intravenous administration of 1g or 500mg of glucocorticoid daily for 3 consecutive days and reduced by half every 3 days. In addition, plasma exchange and immunoabsorption are also optional treatment for the acute phase. Immunomodulatory therapies including low dose of steroid, immunosuppressants (Azathioprine, Mycophenolate, etc.), and disease-modifying therapy (fingolimod, Teriflunomide, Rituximab, Satralizumab, etc.) are necessary for the remission phase.

Other: Traditional Chinese medicine (TCM)
TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.




Primary Outcome Measures :
  1. Annualized Aggregate Relapse Rate (ARR) [ Time Frame: Baseline up to 5 years ]
    ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The ARR was the mean of the annualized ARRs for all patients, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.


Secondary Outcome Measures :
  1. Total Number of Adverse Events During Evaluation [ Time Frame: Baseline up to 5 years ]
    Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

  2. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 5 years ]
    Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

  3. Time to 3-month Sustained Disability Progression [ Time Frame: 5 years ]

    3-month sustained disability progression (DP) was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 3 months.

    EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time.


  4. Time to 6-month Sustained Disability Progression [ Time Frame: 5 years ]

    6-month sustained disability progression (DP) was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 6 months.

    EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time.


  5. Number of New or Newly Enlarging T2 hyperintense lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months ]
    The number of new or newly enlarging T2 hyperintense lesions that developed in each subject compared to baseline assessed on magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.

  6. Number of Gadolinium-enhancing T1-weighted Lesions as Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months ]
    The number of Gd-enhancing lesions was assessed by using MRI scans following administration of gadolinium, a contrast agent.

  7. Percent Change in Brain Volume Measured by Magnetic Resonance Imaging (MRI) [ Time Frame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months ]
    Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library.

  8. Change in Multiple Sclerosis Functional Composite (MSFC) score [ Time Frame: Every 6 months up to 5 years ]
    The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test).

  9. Change in Symbol Digit Modalities Test (SDMT) score [ Time Frame: Every 6 months up to 5 years ]
    The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.

  10. Chance in fatigue severity scale (FSS) score [ Time Frame: Every 6 months up to 5 years ]
    FSS is a short questionnaire that requires patient to rate level of fatigue.

  11. Change in EuroQol- 5 Dimension (EQ-5D) score [ Time Frame: Every 6 months up to 5 years ]
    The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error.

  12. Change from Multiple Sclerosis impact scale (MSIS) score [ Time Frame: Every 6 months up to 5 years ]
    The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error.



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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
DATE-TCM includes all patients with Demyelinating Diseases of the Central Nervous System at beginning of study.
Criteria

Inclusion Criteria:

  • Male or female participants with aged 18-65 years old; Diagnosis of DDC including multiple sclerosis (MS), Neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein-associated disease(MOGAD) according to relevant criteria or consensus; Patients who receive or are willing to receive TCM treatment including the Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong; Informed written consent obtained from the patient, and/or his/her legally authorized representatives.

Exclusion Criteria:

  • Refusal to give informed consent; Malignancies, infectious diseases (HBV, HCV, HIV, etc.), congenital or acquired severe immunodeficiency, significant cardiovascular, pulmonary, and hepatic diseases or conditions; Mental disturbance or severe cognitive impairment impeding necessary information gathering and assessment.

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): NCT05415579


Contacts
Layout table for location contacts
Contact: Ying Gao +86-10-84013209 gaoying973@126.com
Contact: Jia Liu +86-15832127399 liujia860314@163.com

Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Layout table for additonal information
Responsible Party: Ying Gao, Professor, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT05415579    
Other Study ID Numbers: DDCR-TCM-2022
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying Gao, Dongzhimen Hospital, Beijing:
Demyelinating Diseases of the Central Nervous System
Multiple sclerosis
Neuromyelitis optica spectrum disorder
Myelin oligodendrocyte glycoprotein associated disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Demyelinating Diseases
Nervous System Diseases