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Hereditary Spastic ParaplegiaNCT07417943

Neuromodulation to Enhance Motor Function in HSP

A study testing transcutaneous spinal cord stimulation in people with Hereditary Spastic Paraplegia, run by Rahul Sachdeva at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hereditary Spastic Paraplegia
What is being tested?
transcutaneous spinal cord stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
9 Apr 2026to 1 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rahul Sachdeva, PhD contact

8592574888

rahulsachdeva@uky.edu

United States1 site, 1 recruiting

  • University of Kentucky

    Lexington, Kentucky, 40506

    Rahul Sachdeva, PhD, 8592574888, rahulsachdeva@uky.edu

    Vivek K Pandey, PhD, 8592574888, vivek.pandey@uky.edu

    Recruiting

Other trials in United States

About this study

Official title: Noninvasive Spinal Cord Neuromodulation to Enhance Motor Function in Individuals With Hereditary Spastic Paraplegia

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.

Being tested
transcutaneous spinal cord stimulation
Medical subject headings
Spastic Paraplegia, Hereditary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous spinal cord stimulationDevice

    Also called SCONE

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

Study groups in NCT07417943
Study groupRoleWhat they receive
Participants with Hereditary Spastic ParaplegiaExperimentalParticipants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks
Receives: Device: transcutaneous spinal cord stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 10-Meter Walk Test (10MWT)

    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

    Measured: Baseline, Weeks 1, 4, 8, and 16

  2. Change in 6- Minute Walk Test (6MWT)

    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.

    Measured: Baseline, Weeks 1, 4, 8 and 16

  3. Change in Modified Ashworth Scale (MAS)

    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

    Measured: Baseline, Weeks 1, 4, 8, and 16

  4. Change in Spastic Paraplegia Rating Scale (SPRS)

    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.

    Measured: Baseline, Weeks 1, 4, 8, and 16

Secondary outcomes (5)

  1. Change in HSP- Self Notion and Perception (HSP-SNAP) questionnaire

    HSP-SNAP is a questionnaire used to assess the self-perception of individuals diagnosed with hereditary spastic paraplegia (HSP).

    HSP-SNAP includes 12 questions, with 2 items dedicated to each symptom dimension (stiffness, weakness, imbalance, reduced endurance, fatigue, and pain). Each pair of items for a given dimension includes both positive and negative responses to prevent automatic answers. The HSP-SNAP employs a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). To account for both positive and negative items, scoring is as follows: for items with a positive tone, the score is calculated as "patient's score minus 1" (pt score-1); for negative items, the score is "5 minus the patient's score" (5-pt score). The overall score is the sum of all item scores, ranging from 0 to 48. A higher score indicates better well-being and milder symptoms.

    Measured: Baseline, Weeks 1, 4, 8, and 16

  2. Change in Joint Kinematics via Three-dimensional (3D) gait analysis

    3D Gait Analysis will be performed using a 14-camera motion capture system, a wireless Electromyography (EMG) system, and 3 in-ground force plates. We will track walking speed using timing gates. Wireless EMG sensors will be placed on the vastus lateralis, rectus femoris, and vastus medialis to assess muscle activation during the gait trials. The outcomes will include joint kinematics (hip, knee, and ankle,).

    Measured: Baseline, Weeks 1, 4, 8, and 16

  3. Change in Sit-to-stand test

    Participants will be asked to perform a sit-to-stand task, whereby they will be told to stand up and sit down on a stool at their own self-selected pace. Sit-to-Stand performance, measured as the time and kinematic characteristics of sit-to-stand transition (average of two trials) obtained using motion capture analysis.

    Measured: Baseline, Weeks 1, 4, 8, and 16

  4. Change in Bilateral isometric knee strength

    Bilateral isometric knee strength will be obtained with three, 5-sec maximal voluntary isometric contractions (MVIC) separated by one-minute rest. Knee strength, measured as peak knee extensor torque obtained using isokinetic dynamometry (Biodex), expressed in Newton-meters (Nm), with higher values indicating greater muscle strength.

    Measured: Baseline, Weeks 1, 4, 8, and 16

  5. Change in knee pain

    Knee pain during knee strength test is recorded on an 11-point visual analog scale (0=no pain and 10 most pain possible).

    Measured: Baseline, Weeks 1, 4, 8, and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start9 Apr 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07417943
Sponsor's protocol ID
109294
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Deidentified individual participant outcomes data will be published in peer-reviewed journals.

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous spinal cord stimulation in people with Hereditary Spastic Paraplegia, run by Rahul Sachdeva at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rahul Sachdeva, PhD (8592574888, rahulsachdeva@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 10-Meter Walk Test (10MWT) (time frame: Baseline, Weeks 1, 4, 8, and 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07417943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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