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A Prospective Cohort Study of ITB Treatment for HSP

Recruitingn/aAges 14 Years - 70 YearsAllShanghai 6th People's Hospital
NCT06844734 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients meet the clinical and genetic diagnostic criteria of hereditary spastic paraplegia (HSP); * Age: 14 to 70 years old * Modified Ashworth Score for lower limbs: ≥2 joints with muscle tone ≥grade 3 * Patients are willing to participate in clinical trials and able to understand and comply with the research program Exclusion Criteria: * Patients are allergic to the baclofen * Other neurological diseases likely affecting the evaluation of study treatment * Other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year * Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial * Participating in another study drug trial and used the investigational drug in the past 30 days * Subjects have poor compliance or other factors that are not suitable for participating in the clinical trial
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What it tests

  • Not listed
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Where

1 site
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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