Recruiting

tSCS

Sponsor:

Rahul Sachdeva

Code:

NCT07417943

Conditions

Hereditary Spastic Paraplegia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

transcutaneous spinal cord stimulation

Study Details

Brief summary:

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

Hereditary Spastic Paraplegia

Study ID

NCT07417943

Start date

Apr 9, 2026

Status verified date

Feb, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • If wheelchair user: able to perform seated mobility tasks and transfers required for assessments.
  • Capacity to provide informed consent and follow study procedures, with an ability to communicate and understand instructions in English

Exclusion Criteria:

  • 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.
  • Diagnosed with Primary Lateral Sclerosis (PLS) or another neurological condition that affects walking, such as stroke, multiple sclerosis (MS), or a recent surgery on legs.
  • Unable to participate in basic movement or mobility assessments, even with their usual mobility device (such as a wheelchair, walker, or cane). People who use wheelchairs or other mobility aids can participate if they can complete the study's mobility assessments in their usual way.
  • Cognitive or psychiatric conditions that make it difficult to give informed consent or follow study instructions.
  • Diagnosed with Urinary Tract Infection (UTI), either acute or ongoing, before or at the time of study enrollment.
  • Diagnosed with epilepsy.
  • Participation in another interventional clinical trial that could affect mobility or spasticity during the study.
  • A recent change (within the last 4 weeks) in medications or treatments that affect spasticity or movement (for example: baclofen, tizanidine, botulinum toxin injections).
  • Expect to start or change treatments for spasticity or mobility during the study period.
  • Any condition judged by the investigator to pose excess risk or confound outcomes.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Hereditary Spastic Paraplegia

Participants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks

Interventions

transcutaneous spinal cord stimulation

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

Primary outcome measure

  • Change in 10-Meter Walk Test (10MWT) [ Time Frame: Baseline, Weeks 1, 4, 8, and 16 ]
  • Change in 6- Minute Walk Test (6MWT) [ Time Frame: Baseline, Weeks 1, 4, 8 and 16 ]
  • Change in Modified Ashworth Scale (MAS) [ Time Frame: Baseline, Weeks 1, 4, 8, and 16 ]
  • Change in Spastic Paraplegia Rating Scale (SPRS) [ Time Frame: Baseline, Weeks 1, 4, 8, and 16 ]

Central Contacts and Locations

Central contacts

Rahul Sachdeva, PhD

8592574888rahulsachdeva@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Rahul Sachdeva, PhD

8592574888rahulsachdeva@uky.edu

Vivek K Pandey, PhD

8592574888vivek.pandey@uky.edu

More Information

Sponsor

Rahul Sachdeva

Last update posted

Apr 22, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rahul Sachdeva on 2026-04-22.