Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07417943

Neuromodulation to Enhance Motor Function in HSP

Led by Rahul Sachdeva · Updated on 2026-04-22

15

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

Sponsors

R

Rahul Sachdeva

Lead Sponsor

S

Spastic Paraplegia Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neuromodulation to Enhance Motor Function in HSP

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available)
  • Stable medications for spasticity and neurologic symptoms for at least 4 weeks before 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
  • If wheelchair user, able to perform seated mobility tasks and transfers needed for assessments
  • Capacity to provide informed consent and follow study procedures, able to communicate and understand instructions in English
Not Eligible

You will not qualify if you...

  • Implanted electronic devices such as pacemaker, deep brain stimulator, or intrathecal pumps
  • Severe cardiopulmonary disease making participation unsafe
  • Open skin lesions or severe dermatologic conditions at electrode sites
  • Pregnancy or plans to become pregnant during the intervention period
  • Diagnosed with Primary Lateral Sclerosis or other neurological conditions affecting walking like stroke, multiple sclerosis, or recent leg surgery
  • Unable to perform basic movement or mobility assessments even with usual mobility device
  • Cognitive or psychiatric conditions preventing informed consent or following instructions
  • Diagnosed with urinary tract infection before or at enrollment
  • Diagnosed with epilepsy
  • Participation in another interventional trial affecting mobility or spasticity during the study
  • Recent changes (within last 4 weeks) in medications or treatments affecting spasticity or movement
  • Expectation to start or change treatments for spasticity or mobility during the study
  • Any condition judged by the investigator to pose excess risk or confound results

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40506

Actively Recruiting

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Research Team

R

Rahul Sachdeva, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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