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Neuromodulation for Hereditary Spastic Paraplegia

This study is exploring if a treatment called transcutaneous spinal cord stimulation (tSCS) can help adults with Hereditary Spastic Paraplegia (HSP), a condition causing stiffness and walking difficulties. tSCS is a non-surgical method that uses electrodes placed on the skin to deliver electrical pulses to the spinal cord. Researchers want to see if this treatment can improve walking ability and reduce muscle stiffness. To join, you need to be an adult with HSP, have stable medications for at least 4 weeks, and be able to participate in study visits. The study aims to enroll 15 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive tSCS twice a week for 8 weeks, with each session lasting about one hour. You will also have assessments at baseline, and at weeks 1, 4, 8, and 16.
Compensation
Not stated in the trial record.
Follow-up
After the 8-week treatment period, participants will be followed for an additional 8 weeks without stimulation to see if improvements are maintained.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07417943

Neuromodulation to Enhance Motor Function in HSP

Recruiting
NAAges 18+InterventionalTreatment
Rahul Sachdeva
~15 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:transcutaneous spinal cord stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in 10-Meter Walk Test (10MWT)
Measured over Baseline, Weeks 1, 4, 8, and 16
+3 more outcomes measured

Conditions

Hereditary Spastic Paraplegia

Explore related trials

Hereditary Spastic Paraplegia

NCT07417943

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Kentucky

    Lexington, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rahul Sachdeva, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Rahul Sachdeva, PhD
[email protected]
8592574888
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in 10-Meter Walk Test (10MWT)Baseline, Weeks 1, 4, 8, and 16

    10MWT assesses walking speed over a 10-meter walkway at a comfortable and maximum safe pace. Timing occurs between 2 and 8 meters to exclude acceleration/deceleration, with two trials averaged per speed. Assistive devices are allowed

  • Change in 6- Minute Walk Test (6MWT)Baseline, Weeks 1, 4, 8 and 16

    6MWT evaluates walking endurance by measuring the total distance walked over six minutes. Patients are instructed to walk as far as possible at their own pace, with rests allowed if needed. The total distance reflects functional capacity and stamina, which are often affected in HSP due to progressive spasticity and weakness.

  • Change in Modified Ashworth Scale (MAS)Baseline, Weeks 1, 4, 8, and 16

    measures muscle spasticity by assessing resistance to passive muscle stretch through the range of motion and grades the muscle tone on a 0-4 scale based on the resistance felt. MAS 0-4 scale: 0: No increased muscle tone 1: Slight increase in tone; catch and release at the end of the range 1+ : Slight increase; catch followed by minimal resistance through \< half the range 2: More marked increase through most of the range, but the limb still moves easily 3: Considerable increase in tone; passive movement is difficult 4: Limb is rigid in flexion or extension

  • Change in Spastic Paraplegia Rating Scale (SPRS)Baseline, Weeks 1, 4, 8, and 16

    The Spastic Paraplegia Rating Scale (SPRS) is a validated clinical outcome measure used to assess disease severity in individuals with spastic paraplegia. The scale consists of 13 items evaluating gait, spasticity, muscle strength, coordination, and functional impairment. Each item is scored to yield a total score ranging from 0 to 52, where a score of 0 indicates no neurological disability and higher scores reflect increasing severity of impairment, with 52 representing the most severe disease manifestation.