NCT06844734 A Prospective Cohort Study of ITB Treatment for HSP
| NCT ID | NCT06844734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-01-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Li Cao, phD
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Frequently Asked Questions
Who can join the NCT06844734 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 70 Years, studying Hereditary Spastic Paraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06844734 currently recruiting?
Yes, NCT06844734 is actively recruiting participants. Contact the research team at caoli2000@yeah.net for enrollment information.
Where is the NCT06844734 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06844734 clinical trial?
NCT06844734 is sponsored by Shanghai 6th People's Hospital. The principal investigator is Li Cao, phD at Shanghai Jiao Tong University Affiliated Sixth People's Hospital. The trial plans to enroll 50 participants.