Neuromodulation to Enhance Motor Function in HSP

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Rahul Sachdeva
Study ID
NCT07417943
Status
Recruiting
Apply to this trial

Conditions

  • Hereditary Spastic Paraplegia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • transcutaneous spinal cord stimulation — DEVICE
    a non-invasive spinal neuromodulation system will deliver stimulation as high-frequency pulsed current using frequencies within a predefined range

Study Details

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.

Key Dates

Start date
Apr 9, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Hereditary Spastic Paraplegia
    Participants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks

Primary Outcome Measure

Change in 10-Meter Walk Test (10MWT) [ Time Frame: Baseline, Weeks 1, 4, 8, and 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Rahul Sachdeva, PhD
[email protected]
8592574888
Vivek K Pandey, PhD
[email protected]
8592574888

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By research site
University of Kentucky· Lexington, KY

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