Demyelinating Diseases of the Central Nervous System (DDC)NCT05415579
Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
An observational study of Demyelinating Diseases of the Central Nervous System (DDC), run by Dongzhimen Hospital, Beijing.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Demyelinating Diseases of the Central Nervous System (DDC)
- What is being tested?
- Traditional Chinese medicine (TCM)
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2022to 31 May 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: DATE-TCM includes all patients with Demyelinating Diseases of the Central Nervous System at beginning of study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Traditional Chinese medicine (TCM)
- Keywords
- Demyelinating Diseases of the Central Nervous System, Multiple sclerosis, Neuromyelitis optica spectrum disorder, Myelin oligodendrocyte glycoprotein associated disorder
- Medical subject headings
- Demyelinating Diseases, Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine (TCM)Other
TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Traditional Chinese medicine (TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Aggregate Relapse Rate (ARR)
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.
Measured: Baseline up to 5 years
Secondary outcomes (12)
Total Number of Adverse Events During Evaluation
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.
Measured: Baseline up to 5 years
Percentage of Participants With Adverse Events
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.
Measured: Baseline up to 5 years
Time to 3-month Sustained Disability Progression
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.
Measured: 5 years
Time to 6-month Sustained Disability Progression
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.
Measured: 5 years
Number of New or Newly Enlarging T2 hyperintense lesions as Measured by Magnetic Resonance Imaging (MRI)
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.
Measured: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
Number of Gadolinium-enhancing T1-weighted Lesions as Measured by Magnetic Resonance Imaging (MRI)
The number of Gd-enhancing lesions was assessed by using MRI scans following administration of gadolinium, a contrast agent.
Measured: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
Percent Change in Brain Volume Measured by Magnetic Resonance Imaging (MRI)
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.
Measured: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
Change in Multiple Sclerosis Functional Composite (MSFC) score
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).
Measured: Every 6 months up to 5 years
Change in Symbol Digit Modalities Test (SDMT) score
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.
Measured: Every 6 months up to 5 years
Chance in fatigue severity scale (FSS) score
FSS is a short questionnaire that requires patient to rate level of fatigue.
Measured: Every 6 months up to 5 years
Change in EuroQol- 5 Dimension (EQ-5D) score
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.
Measured: Every 6 months up to 5 years
Change from Multiple Sclerosis impact scale (MSIS) score
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.
Measured: Every 6 months up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start20 Jun 2022 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demyelinating Diseases of the Central Nervous System (DDC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415579
- Sponsor's protocol ID
- DDCR-TCM-2022
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
- ClinicalTrials.gov ID
- NCT05415579
- Acronym / sponsor ID
- DDCR-TCM-2022
- Keywords
- Demyelinating Diseases of the Central Nervous System, Multiple sclerosis, Neuromyelitis optica spectrum disorder, Myelin oligodendrocyte glycoprotein associated disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDC patients with Traditional Chinese medicine (TCM) treatment | – | Other: Traditional Chinese medicine (TCM)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DATE-TCM includes all patients with Demyelinating Diseases of the Central Nervous System at beginning of study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicine (TCM)TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong. | Other | DDC patients with Traditional Chinese medicine (TCM) treatment |
Primary outcome
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.
12 secondary outcomes
Total Number of Adverse Events During Evaluation
Time frame: Baseline up to 5 years
Percentage of Participants With Adverse Events
Time frame: Baseline up to 5 years
Time to 3-month Sustained Disability Progression
Time frame: 5 years
Time to 6-month Sustained Disability Progression
Time frame: 5 years
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
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
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
Change in Multiple Sclerosis Functional Composite (MSFC) score
Time frame: Every 6 months up to 5 years
Change in Symbol Digit Modalities Test (SDMT) score
Time frame: Every 6 months up to 5 years
Chance in fatigue severity scale (FSS) score
Time frame: Every 6 months up to 5 years
Change in EuroQol- 5 Dimension (EQ-5D) score
Time frame: Every 6 months up to 5 years
Change from Multiple Sclerosis impact scale (MSIS) score
Time frame: Every 6 months up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Demyelinating Diseases of the Central Nervous System (DDC), run by Dongzhimen Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Gao (+86-10-84013209, gaoying973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Aggregate Relapse Rate (ARR) (time frame: Baseline up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.