Actively Recruiting
Intrathecal Baclofen Treatment for Hereditary Spastic Paraparesis A Prospective Cohort Study Evaluating Effects and Timing
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
Researchers are evaluating the effectiveness of continuous intrathecal baclofen (ITB) infusion to treat hereditary spastic paraplegia (HSP) in China. This prospective cohort study aims to understand how ITB affects gait, motor function, spasticity, quality of life, pain, psychological status, cognition, complications, skeletal deformities, and differences in outcomes across genetic subtypes. The study also seeks to determine the best time to start ITB treatment for HSP patients. The trial is open-label and conducted at a single center over three years. It will enroll 50 patients aged 14 to 70 with a Modified Ashworth Scale score of 3 or higher in at least two lower limb joints. Twenty-five patients will receive ITB via surgical pump implantation, while 25 others will receive oral baclofen as a control group. Patients who do not agree to ITB or do not respond adequately to an ITB test will be assigned to oral baclofen and followed naturally. Both groups receive regular professional clinical evaluations. Participants will be monitored using measures including the Six-Minute Walk Test, step length, walking speed, knee flexion angle, Modified Ashworth Scale, and joint range of motion. These assessments occur at the end of treatment and at 6, 12, 18, 24, 30, and 36 months afterward. The study collects data on motor function, spasticity, and physical mobility over time to evaluate the long-term impact and safety of ITB treatment compared to oral baclofen.
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
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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
W
Wotu Tian, phD
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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