A Prospective Cohort Study of ITB Treatment for HSP

Recruiting now

Conditions studied: Hereditary Spastic Paraplegia

In brief

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.

Key facts

Study ID

NCT06844734

Run by

Shanghai 6th People's Hospital

People needed

50

Starts

2025-01-01

Expected to finish

2028-03-01

Last updated by the study team

2025-02-26

Who can join

Age: 14 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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