Exploring intrathecal baclofen treatment for hereditary spastic paraplegia
Intrathecal Baclofen for the Management of Hereditary Spastic Paraparesis: a Prospective Cohort Study
Shanghai 6th People's Hospital · NCT06844734
This study is testing if a special pump that delivers baclofen directly into the spine can help people with hereditary spastic paraplegia improve their movement and quality of life better than taking the medication by mouth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06844734 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of continuous infusion of intrathecal baclofen (ITB) for patients with hereditary spastic paraplegia (HSP) in China. It aims to assess changes in gait, motor function, spasticity levels, quality of life, and psychological status before and after ITB surgery compared to a control group receiving oral baclofen. The study will also evaluate complications following ITB surgery and its impact on skeletal deformities. A total of 50 patients aged 14 to 70 years will participate over a 3-year period, with half receiving ITB and half receiving oral baclofen.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 to 70 years diagnosed with hereditary spastic paraplegia and exhibiting significant spasticity.
Not a fit: Patients with other neurological diseases or those who are allergic to baclofen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and functional abilities of patients with hereditary spastic paraplegia.
How similar studies have performed: While the use of intrathecal baclofen for spasticity has been explored, this specific application for hereditary spastic paraplegia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Li Cao, phD — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study coordinator: Li Cao, phD
- Email: caoli2000@yeah.net
- Phone: +86 21 64369263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hereditary Spastic Paraplegia, Hereditary Spastic Paraparesis, Intrathecal baclofen