A novel scoring system for assessing adult syringomyelia associated with CM I treatment outcomes.
Jian Guan, Chenghua Yuan, Qingyu Yao...
https://pubmed.ncbi.nlm.nih.gov/37046133Actively Recruiting
Phase 2
Age: 18Years - 80Years
All Genders
ID06308367
The Effect of Betaine in Refractory Syringomyelia (RS)
Led by Xuanwu Hospital, Beijing · Updated on 2024-03-13
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of betaine in people with refractory syringomyelia, a condition where fluid-filled cysts develop within the spinal cord. This trial aims to evaluate the indications, therapeutic effects, and side effects of betaine, an osmotic homeostasis-related drug, particularly for post-traumatic syringomyelia. The study focuses on patients who have not responded well to standard treatments like duraplasty or shunting. This is a phase 2 clinical trial sponsored by Xuanwu Hospital, Beijing. Participants will be randomly assigned to receive either oral betaine at a dose of 50mg/kg for 12 weeks or a placebo of rice flour. The study uses a quadruple masking design, meaning that participants, care providers, investigators, and outcomes assessors are all unaware of group assignments. The trial began in March 2024 and is expected to continue until March 2028. During the study, participants will be assessed using the ASIA score before treatment and at 3 days and 3 months after treatment. Other evaluations include syringomyelia remission, electrophysiology results, pain levels measured by the Visual Analog Scale, syringomyelia scales, and incidence of complications. Researchers will monitor safety and efficacy throughout the trial. Total participation duration includes treatment and follow-up assessments over several months.
CONDITIONS
Brief Title
The Therapeutic Effect of Betaine in Syringomyelia
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects
- No effective response to duraplasty and shunting treatment in the 12 months prior to study entry
- Estimated life expectancy greater than 12 months
- Ability to understand and willingness to sign written informed consent, or a caregiver who can do so
- Ability to swallow tablets
You will not qualify if you...
- Use of prescribed medications for cardiometabolic disease
- Evidence of tumor metastasis, recurrence, or invasion
- History of psychiatric diseases
- History of seizures
- History of arteriosclerotic cardiovascular diseases (e.g., stroke, myocardial infarction, unstable angina) within 6 months
- New York Heart Association Grade II or greater congestive heart failure
- Serious and inadequately controlled cardiac arrhythmia
- Significant vascular disease (e.g., moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection)
- Severe infection
- History of allergy to relevant drugs
- Pregnancy, lactation, or fertility plans within 12 months
- History or current diagnosis of peripheral nerve disease
- Abnormal liver or kidney function
- Active tuberculosis
- Transplanted organs
- Human immunodeficiency virus infection
- Participation in other experimental studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive oral betaine or placebo for refractory syringomyelia to evaluate therapeutic effects and safety.
Visits 1 day before treatment, 3 days after treatment start, and at 3 months after treatment
Trial Site Locations
Total: 1 location
1
Fengzeng Jian
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
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Research Team
J
jian fengzeng
C
chenghua yuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Spinal Cord Transcriptomic and Metabolomic Analysis after Excitotoxic Injection Injury Model of Syringomyelia.
Ashley E Mohrman, Mahmoud Farrag, He Huang...
https://pubmed.ncbi.nlm.nih.gov/27736311Analysis of 70 patients with hydrocephalus due to cobalamin C deficiency.
Ruxuan He, Hongwu Zhang, Lulu Kang...
https://pubmed.ncbi.nlm.nih.gov/32943488Aquaporin-4 expression and blood-spinal cord barrier permeability in canalicular syringomyelia.
Sarah J Hemley, Lynne E Bilston, Shaokoon Cheng...
https://pubmed.ncbi.nlm.nih.gov/23082850Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis.
Chenghua Yuan, Pingchuan Xia, Wanru Duan...
https://pubmed.ncbi.nlm.nih.gov/38014747Cerebrospinal Fluid Hydrodynamics in Chiari I Malformation and Syringomyelia: Modeling Pathophysiology.
John D Heiss
https://pubmed.ncbi.nlm.nih.gov/36424067Intradural Pathology Causing Cerebrospinal Fluid Obstruction in Syringomyelia and Effectiveness of Foramen Magnum and Foramen of Magendie Dredging Treatment.
Jian Guan, Chenghua Yuan, Can Zhang...
https://pubmed.ncbi.nlm.nih.gov/32805463Suppression of TGFβR-Smad3 pathway alleviates the syrinx induced by syringomyelia.
Sumei Liu, Longbing Ma, Boling Qi...
https://pubmed.ncbi.nlm.nih.gov/37248485