Actively Recruiting
Noninvasive Spinal Cord Neuromodulation to Enhance Motor Function in Individuals With Hereditary Spastic Paraplegia
Led by Rahul Sachdeva · Updated on 2026-04-22
15
Participants Needed
1
Research Sites
4 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
Researchers are evaluating whether a noninvasive technique called transcutaneous spinal cord stimulation (tSCS) can improve walking ability and reduce muscle stiffness in adults with hereditary spastic paraplegia (HSP), a rare neurological condition causing nerve damage that leads to stiffness, weakness, and walking difficulties. The study is focused on adults diagnosed with HSP and aims to explore changes in motor function and disease severity. Participants will undergo 16 sessions of tSCS over 8 weeks, receiving stimulation twice weekly through self-adhesive electrodes placed on the skin over the lower back. Each session lasts about one hour and does not require surgery. Following this treatment phase, participants will be monitored for an additional 8 weeks without stimulation to assess whether any improvements continue. During the study, researchers will assess walking speed using the 10-Meter Walk Test and walking endurance with the 6-Minute Walk Test at multiple time points. Muscle stiffness, disease severity, bladder and bowel function, muscle strength, joint movement, sit-to-stand ability, and knee pain will also be evaluated. These assessments occur at baseline and at weeks 1, 4, 8, and 16, tracking progress during and after stimulation. Participants will complete questionnaires and physical tests to provide comprehensive data on the effects of tSCS.
CONDITIONS
Brief Title
Neuromodulation to Enhance Motor Function in HSP
Who Can Participate
Eligibility Criteria
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
- Ability 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, and understand instructions in English
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 skin 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 or multiple sclerosis
- Unable to participate in basic movement or mobility assessments even with usual assistive devices
- Cognitive or psychiatric conditions impairing consent or following instructions
- Active or recent urinary tract infection at enrollment
- Diagnosis of epilepsy
- Participation in another interventional trial affecting mobility or spasticity
- Recent changes in spasticity-related medications or treatments within 4 weeks before enrollment
- Expectation to start or change spasticity or mobility treatments during the study
- Any condition judged by investigators to pose excess risk or confound results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants undergo transcutaneous spinal cord stimulation sessions to enhance motor function.
16 sessions over 8 weeks
Duration - 8 weeks
Participants are monitored after the intervention to assess changes in motor function and spasticity.
Visits at Weeks 8 and 16 for assessments
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
R
Rahul Sachdeva, PhD
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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