A Prospective Cohort Study of ITB Treatment for HSP
ConditionHereditary Spastic Paraplegia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-70
SponsorShanghai 6th People's Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov