About this trial
Hereditary spastic paraplegia (HSP) is a rare neurological condition that causes stiffness, weakness, and difficulty walking due to damage in the nerves that control movement. This study will test whether a noninvasive form of spinal cord stimulation, called transcutaneous spinal cord stimulation (tSCS), can improve walking and reduce muscle stiffness in adults with HSP.
In this study, participants will receive tSCS twice a week for 8 weeks. The stimulation is delivered through self-adhesive electrodes placed on the skin over the lower back and does not require surgery. Each session will last about one hour. After the treatment period, participants will be followed for an additional 8 weeks without stimulation to see whether any improvements are maintained. Researchers will measure walking speed, walking endurance, muscle stiffness, and overall disease severity. Additional tests will explore changes in bladder and bowel function and muscle strength.
Eligibility criteria
Qualifiers
Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available).
Stable medications for spasticity and other neurologic symptoms for =4 weeks prior to enrollment.
Able to participate in study visits and assessments with or without assistive devices.
If ambulatory: able to walk at least 10 meters with or without an assistive device.
Disqualifiers
Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps).
Severe cardiopulmonary disease that would make participation unsafe.
Open skin lesions or severe dermatologic conditions at electrode sites.
Pregnancy or plans to become pregnant during the intervention period.
Trial design
Treatments tested in this trial
- transcutaneous spinal cord stimulation
Treatment groups
Sponsors and collaborators
Rahul Sachdeva
Lead sponsor
University of Kentucky
Sponsor institution
Spastic Paraplegia Foundation
Collaborator