Actively Recruiting
A Prospective Cohort Study of ITB Treatment for HSP
Led by Shanghai 6th People's Hospital · Updated on 2025-02-26
50
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators conduct a prospective cohort study to explore the treatment effectiveness of continuous infusion of intrathecal baclofen (ITB) for hereditary spastic paraplegia (HSP) in China, delve into the optimal timing for starting treatment, and investigate the response differences among different subtypes. The ultimate goal is to provide clinical evidence and guidance for the application of ITB in treating HSP in China, as well as improve the life expectancy and quality of life for HSP patients. The main questions it aims to answer are: 1. Changes in gait and motor function, as well as spasticity levels, compared to pre-surgery and control group after ITB surgery. 2. Changes in quality of life, pain, psychological and emotional status, and cognition compared to pre-surgery and control group after ITB surgery. 3. Complications following ITB surgery. 4. Impact of ITB surgery on the occurrence and progression of skeletal deformities. 5. Subgroup analysis: comparing surgical outcomes between different genotypes and between simple versus complex types. 6. Determine the optimal timing for ITB intervention.
CONDITIONS
Official Title
A Prospective Cohort Study of ITB Treatment for HSP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients meet the clinical and genetic diagnostic criteria of hereditary spastic paraplegia (HSP)
- Age between 14 and 70 years old
- Modified Ashworth Score for lower limbs: 2 or more joints with muscle tone grade 3 or higher
- Willing to participate in clinical trials and able to understand and comply with the research program
You will not qualify if you...
- Allergy to baclofen
- Other neurological diseases likely affecting study treatment evaluation
- Medical conditions such as heart disease, tumor, blood disease, liver disease, or kidney disease within the past year
- Pregnancy, lactation, or inability to use appropriate contraception during the trial
- Participation in another drug study or investigational drug use within the past 30 days
- Poor compliance or other factors unsuitable for participating in the clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 213000
Actively Recruiting
Research Team
L
Li Cao, phD
CONTACT
W
Wotu Tian, phD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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