Neuromodulation to Enhance Motor Function in HSP

NCT07417943 | Recruiting FDA Device

• 1 other identifier: 109294
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline, Weeks 1, 4, 8, and 16

• 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.

  Baseline, Weeks 1, 4, 8 and 16

• 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

  Baseline, Weeks 1, 4, 8, and 16

• 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.

  Baseline, Weeks 1, 4, 8, and 16

Secondary Outcomes (5)

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

  Baseline, Weeks 1, 4, 8, and 16

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

  Baseline, Weeks 1, 4, 8, and 16

• Change in Sit-to-stand test

  Baseline, Weeks 1, 4, 8, and 16

• Change in Bilateral isometric knee strength

  Baseline, Weeks 1, 4, 8, and 16

• Change in knee pain

  Baseline, Weeks 1, 4, 8, and 16

Other Outcomes (3)

• Change in Neurogenic Bladder Symptom Score (NBSS)

  Baseline, Weeks 1, 4, 8, and 16

• Change in Neurogenic bowel dysfunction score (NBD Score)

  Baseline, Weeks 1, 4, 8, and 16.

• Change in Metabolic/protein profiling

  Baseline, Weeks 1, 4, 8, and 16

Study Arms (1)

Participants with Hereditary Spastic Paraplegia

EXPERIMENTAL

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

Device: transcutaneous spinal cord stimulation

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

Also known as: SCONE

Participants with Hereditary Spastic Paraplegia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rahul Sachdeva: lead
• Spastic Paraplegia Foundation: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Rahul Sachdeva, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahul Sachdeva, PhD

CONTACT

8592574888; rahulsachdeva@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)