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A Prospective Cohort Study of ITB Treatment for HSP

NCT06844734 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-02-26

No results posted yet for this study

Summary

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

  • Hereditary Spastic Paraplegia

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    lead OTHER

Principal Investigators

  • Li Cao, phD · Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-03-01
Completion
2028-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06844734 on ClinicalTrials.gov