Who may be eligible for the Neuromodulation to Enhance Motor Function in HSP trial?

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.

ClinicalTrials.gov record NCT07417943

Neuromodulation to Enhance Motor Function in HSP

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study tests a noninvasive spinal cord stimulation device (tSCS) in adults with hereditary spastic paraplegia (HSP). Participants receive 16 stimulation sessions (about one hour each) twice weekly over 8 weeks, then are followed for 8 more weeks without stimulation. Researchers measure walking speed and endurance, muscle stiffness, disease severity, gait mechanics, and muscle strength.

What it is studying. The study tests whether repeated sessions of transcutaneous spinal cord stimulation (stimulation delivered through skin electrodes over the lower back) produce measurable changes in walking ability, reduce muscle spasticity, or change muscle strength and overall disease severity in people with HSP. It also explores gait mechanics and bladder/bowel function and collects patient-reported symptom data.

What the researchers hope to learn. Scientific goals: measure effects of tSCS on walking speed (10-Meter Walk Test), walking endurance (6-Minute Walk Test), muscle spasticity (Modified Ashworth Scale), and disease severity (Spastic Paraplegia Rating Scale). The study also aims to characterize changes in gait kinematics, sit-to-stand performance, knee strength, knee pain, and patient-reported symptoms (HSP-SNAP), and to explore bladder and bowel function.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device: transcutaneous spinal cord stimulation

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive noninvasive transcutaneous spinal cord stimulation (tSCS) through self-adhesive electrodes on the lower back twice weekly for 8 weeks (16 sessions), with each session lasting about one hour and no surgery required. Assessments occur at baseline and at Weeks 1, 4, 8 (end of treatment) and 16 (8-week follow-up) and include walking tests (10-meter and 6-minute), spasticity ratings (Modified Ashworth Scale), the Spastic Paraplegia Rating Scale, questionnaires, 3D gait analysis with motion capture and EMG, sit-to-stand testing, and knee strength measurements. Assistive devices are allowed; wheelchair users may participate if they can complete the required mobility assessments. The registry does not list any participant support services or other study-specific benefits.

How the study is structured. Single-group interventional study: all participants receive active transcutaneous spinal cord stimulation (tSCS). No masking. Treatment is given twice weekly for 8 weeks (16 sessions total), each session about one hour, followed by an 8-week observation period without stimulation. Outcomes are measured at baseline and at weeks 1, 4, 8, and 16.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on hereditary spastic paraplegia

Clinical trials21 trials listed for hereditary spastic paraplegiaEvery trial the registry lists for hereditary spastic paraplegia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hereditary spastic paraplegia researchLatest monthly update: September 2026. Includes: SPTSSA treatment signal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Apr 9, 2026
Primary completion: Dec 31, 2027 (estimated)
Study completion: Feb 1, 2028 (estimated)
Target enrollment: 15 participants (estimated)
Last updated on registry: Apr 22, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Rahul Sachdeva
Collaborators: Spastic Paraplegia Foundation

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

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

Participating sites (1)

University of KentuckyRecruiting
Lexington, Kentucky, 40506 · United States
- Rahul Sachdeva, PhD · 8592574888 · rahulsachdeva@uky.edu
- Vivek K Pandey, PhD · 8592574888 · vivek.pandey@uky.edu

Terms used on this page · explanations by MedicalUpdates.ai

enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
intrathecal: Given by injection into the fluid around the spinal cord, usually through a lumbar puncture.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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