Intrathecal Baclofen for the Management of Hereditary Spastic Paraparesis: a Prospective Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Li Cao, phD
caoli2000@yeah.net
+86 21 64369263
Backup
Wotu Tian, phD
wotu_tian@163.com
+86 21 64369181
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 50
Treatments
Intrathecal baclofen management of hereditary spastic paraparesis
Patients with hereditary spastic paraparesis aged 14 to 70 years, with a Modified Ashworth Scale score of greater or equal to 3 in 2 or more joints of lower limb, and agree to undergo Intrathecal baclofen surgery will be recruited. Patients will receive professional assessment every six months.
The oral baclofen group
Patients who do not agree to intrathecal baclofen treatment or those who do not achieve satisfactory therapeutic effect during the baclofen testing phase will be included in oral baclofen group. Patients will receive professional assessment every six months, with natural history observation.
Sponsors
Leads: Shanghai 6th People's Hospital

This content was sourced from clinicaltrials.gov