An interventional study of transcutaneous spinal cord stimulation in Hereditary Spastic Paraplegia, sponsored by Rahul Sachdeva. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Rahul Sachdeva · Not applicable, Interventional, and Treatment
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.
45 studies on the registry are indexed under Spastic Paraplegia, Hereditary; 19 are open to participants now.
This study's planned enrollment of 15 is below the median of 25 across 20 interventional studies indexed under Spastic Paraplegia, Hereditary.
Browse Spastic Paraplegia, Hereditary studies →This is the only study on the registry with Rahul Sachdeva as lead sponsor.
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Participants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks
Device: transcutaneous spinal cord stimulation
a non-invasive spinal neuromodulation system will deliver stimulation as high-frequency pulsed current using frequencies within a predefined range
Also known as: SCONE
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, Weeks 1, 4, 8, and 16
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.
Time frame: Baseline, Weeks 1, 4, 8, and 16
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,).
Time frame: Baseline, Weeks 1, 4, 8, and 16
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.
Time frame: Baseline, Weeks 1, 4, 8, and 16
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.
Time frame: Baseline, Weeks 1, 4, 8, and 16
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).
Time frame: Baseline, Weeks 1, 4, 8, and 16
Change in Neurogenic Bladder Symptom Score (NBSS)
The Neurogenic Bladder Symptom Score (NBSS) is a validated, disease-specific patient-reported outcome measure designed to assess lower urinary tract symptoms in individuals with neurogenic bladder. The questionnaire evaluates symptom severity across three domains, including incontinence, storage and voiding symptoms, and bladder-related consequences, as well as a global quality-of-life item. Individual items are scored on ordinal response scales, and summed to generate a total score ranging from 0 to 74, with higher scores indicating greater urinary symptom severity and impact on daily functioning.
Time frame: Baseline, Weeks 1, 4, 8, and 16
Change in Neurogenic bowel dysfunction score (NBD Score)
The Neurogenic Bowel Dysfunction Score (NBDS) is a validated clinical questionnaire used to assess the severity and impact of bowel dysfunction in individuals with neurological conditions, including spinal cord injury. The instrument evaluates multiple domains of bowel function, including frequency of defecation, constipation, fecal incontinence, use of medication or mechanical assistance, and impact on quality of life. Individual item scores are summed to yield a total score ranging from 0 to 47, with higher scores indicating more severe bowel dysfunction and greater impact on daily living.
Time frame: Baseline, Weeks 1, 4, 8, and 16.
Change in Metabolic/protein profiling
Approximately 10 mL of venous blood samples will be collected and processed for metabolomic/lipid profiling and biomarker assays
Time frame: Baseline, Weeks 1, 4, 8, and 16
Plan to share: Yes — Deidentified individual participant outcomes data will be published in peer-reviewed journals.
Supporting information: Study protocol, Sap
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