Clinical trial NCT05415579: Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
Official title: Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Demyelinating Diseases of the Central Nervous System (DDC)
Keywords: Demyelinating Diseases of the Central Nervous System
Multiple sclerosis
Neuromyelitis optica spectrum disorder
Myelin oligodendrocyte glycoprotein associated disorder
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DATE-TCM includes all patients with Demyelinating Diseases of the Central Nervous System at beginning of study.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Annualized Aggregate Relapse Rate (ARR)
timeFrame: Baseline up to 5 years
Secondary outcomes:
measure: Total Number of Adverse Events During Evaluation
timeFrame: Baseline up to 5 years
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to 5 years
measure: Time to 3-month Sustained Disability Progression
timeFrame: 5 years
measure: Time to 6-month Sustained Disability Progression
timeFrame: 5 years
measure: Number of New or Newly Enlarging T2 hyperintense lesions as Measured by Magnetic Resonance Imaging (MRI)
timeFrame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
measure: Number of Gadolinium-enhancing T1-weighted Lesions as Measured by Magnetic Resonance Imaging (MRI)
timeFrame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
measure: Percent Change in Brain Volume Measured by Magnetic Resonance Imaging (MRI)
timeFrame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
measure: Change in Multiple Sclerosis Functional Composite (MSFC) score
timeFrame: Every 6 months up to 5 years
measure: Change in Symbol Digit Modalities Test (SDMT) score
timeFrame: Every 6 months up to 5 years
measure: Chance in fatigue severity scale (FSS) score
timeFrame: Every 6 months up to 5 years
measure: Change in EuroQol- 5 Dimension (EQ-5D) score
timeFrame: Every 6 months up to 5 years
measure: Change from Multiple Sclerosis impact scale (MSIS) score
timeFrame: Every 6 months up to 5 years
Other outcomes:
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