Exploring intrathecal baclofen treatment for hereditary spastic paraplegia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rare Disease Registry for Movement Disorders in Southern Anhui

  This project is creating a registry to collect information from adults with motor neuron diseases, spinocerebellar ataxias, hereditary muscular dystrophy, or hereditary spastic paraplegia in Southern Anhui.

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• TreatHSP/SPAX: An adaptive natural history platform for SPAX diseases

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• Noninvasive spinal stimulation to improve walking in hereditary spastic paraplegia

  This trial will test whether noninvasive transcutaneous spinal cord stimulation can improve walking and reduce muscle stiffness in adults with hereditary spastic paraplegia.

  Recruiting University of Kentucky · Lexington, Kentucky · NCT07417943

• Wearable monitoring of walking and arm movement in adults with neuromuscular or metabolic movement disorders

  This project uses a wrist/ankle wearable to continuously monitor walking and upper-limb movement in ambulant adults with neuromuscular diseases or obesity to see if digital measures like stride speed track real-life motor function.

  Recruiting Centre Hospitalier Universitaire de Liege · Liège · NCT07136844

• Evaluating surgical treatment for foot deformities in hereditary spastic paraplegia

  This study is testing how well surgery can help people with hereditary spastic paraplegia and foot deformities feel and function better over two years.

  Recruiting Shanghai 6th People's Hospital · Shanghai, Shanghai Municipality · NCT06936163

• Robot-assisted walking treatment for hereditary spastic paraplegia

  This study is testing whether using a robot to help with walking, along with regular physical therapy, can improve movement and quality of life for people with hereditary spastic paraplegia.

  Recruiting IRCCS Eugenio Medea · Bosisio Parini, Italy/lecco · NCT06728787

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.