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

What this Trial Is About

Researchers are studying hereditary spastic paraplegia (HSP), a group of disorders causing progressive stiffness and weakness in the legs. This study explores how continuous infusion of intrathecal baclofen (ITB), delivered via a surgical pump, compares to oral baclofen for treating spasticity in HSP patients. The trial aims to find the best time to start ITB treatment and understand differences in response among various HSP types. It is a prospective, open-label study conducted over three years in China with 50 participants aged 14 to 70 years. Participants are divided into two groups: one receiving ITB through surgery, and the other receiving oral baclofen if they decline or do not respond well to ITB testing. Both groups undergo professional assessments every six months. The study will monitor changes in walking ability, muscle tone, joint movement, quality of life, pain, mental health, cognition, and complications. It also examines how ITB affects skeletal deformities and compares outcomes between genetic subtypes and simple versus complex HSP. Throughout the study, patients will be evaluated regularly at 6, 12, 18, 24, 30, and 36 months after treatment begins. Assessments include the Six-Minute Walk Test, step length, walking speed, knee flexion angle, Modified Ashworth Scale, joint range of motion, and various scales measuring disability, pain, cognition, depression, anxiety, and spasticity. Researchers will also track complications and deformity changes. This comprehensive monitoring helps assess the safety and effectiveness of ITB over time and aims to improve care for HSP patients.

A Prospective Cohort Study of ITB Treatment for HSP