Transcutaneous spinal cord stimulation for functional recovery in individuals with hereditary spastic paraplegia: Protocol for a pilot clinical trial
8 affiliations
- 1Department of Physical Medicine and Rehabilitation, University of Kentucky, Lexington, United States of America
- 2Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, United States of America
- 3Spinal Cord and Brain Injury Research Center (SCoBIRC), University of Kentucky, Lexington, United States of America
- 4Department of Physiology, University of Kentucky, Lexington, United States of America
- 5SpineX Inc, Los Angeles, California, United States of America
- 6Independent Consultant, Chapel Hill, North Carolina, United States of America
- 7Person with Lived Experience, Lexington, United States of America
- 8Department of Neurobiology and Anatomy, College of Medicine, Drexel University, Philadelphia, United States of America
Abstract
Background: Hereditary spastic paraplegia (HSP) is a rare genetic neurodegenerative disorder characterized by progressive lower-extremity spasticity, weakness, and gait impairment resulting from corticospinal tract degeneration. With no disease-modifying therapies available, novel strategies to improve motor function are needed. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation approach that may improve motor function but has not been prospectively evaluated in HSP. This study will assess the safety, feasibility, and preliminary efficacy of repeated tSCS in adults with HSP. Methods and analysis: This prospective, open-label, single-arm pilot trial will enroll 15 adults with HSP. Participants will receive 16 tSCS sessions over 8 weeks targeting the lower thoracic and upper lumbar vertebral levels, followed by an 8-week follow-up. Outcomes will assess gait performance, spasticity, disease severity, mobility, walking endurance, muscle strength, 3D gait biomechanics, electromyography, and HSP-specific patient-reported measures. Exploratory blood-based neurodegenerative biomarkers and metabolomic and lipidomic profiles will investigate potential biological correlates of treatment response. Assessments will occur at baseline and weeks 4, 8, and 16. Feasibility and safety will be evaluated through recruitment, retention, adherence, and adverse events.
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BibTeX
@article{pandey2026transcutaneous,
title = {{Transcutaneous spinal cord stimulation for functional recovery in individuals with hereditary spastic paraplegia: Protocol for a pilot clinical trial}},
author = {Vivek K. Pandey and Holly M. Elliott and Amara G. Sharp and Emma S. Ballenger and Zamiar Karianne and Parag Gad and Rich Cohn and Aaron G. Taylor and Emanuela Piermarini and Peter W. Baas and Samir P. Patel and Sara S. Salles and Zakari R. Dymock and Michael A. Samaan and Rahul Sachdeva},
journal = {PLOS One},
year = {2026},
month = oct,
doi = {10.1371/journal.pone.0359948},
url = {https://doi.org/10.1371/journal.pone.0359948},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Transcutaneous spinal cord stimulation for functional recovery in individuals with hereditary spastic paraplegia: Protocol for a pilot clinical trial
AU - Vivek K. Pandey
AU - Holly M. Elliott
AU - Amara G. Sharp
AU - Emma S. Ballenger
AU - Zamiar Karianne
AU - Parag Gad
AU - Rich Cohn
AU - Aaron G. Taylor
AU - Emanuela Piermarini
AU - Peter W. Baas
AU - Samir P. Patel
AU - Sara S. Salles
AU - Zakari R. Dymock
AU - Michael A. Samaan
AU - Rahul Sachdeva
PY - 2026
DA - 2026/10/15
JO - PLOS One
DO - 10.1371/journal.pone.0359948
UR - https://doi.org/10.1371/journal.pone.0359948
AB - Background: Hereditary spastic paraplegia (HSP) is a rare genetic neurodegenerative disorder characterized by progressive lower-extremity spasticity, weakness, and gait impairment resulting from corticospinal tract degeneration. With no disease-modifying therapies available, novel strategies to improve motor function are needed. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation approach that may improve motor function but has not been prospectively evaluated in HSP. This study will assess the safety, feasibility, and preliminary efficacy of repeated tSCS in adults with HSP. Methods and analysis: This prospective, open-label, single-arm pilot trial will enroll 15 adults with HSP. Participants will receive 16 tSCS sessions over 8 weeks targeting the lower thoracic and upper lumbar vertebral levels, followed by an 8-week follow-up. Outcomes will assess gait performance, spasticity, disease severity, mobility, walking endurance, muscle strength, 3D gait biomechanics, electromyography, and HSP-specific patient-reported measures. Exploratory blood-based neurodegenerative biomarkers and metabolomic and lipidomic profiles will investigate potential biological correlates of treatment response. Assessments will occur at baseline and weeks 4, 8, and 16. Feasibility and safety will be evaluated through recruitment, retention, adherence, and adverse events.
SN - 1932-6203
ER -