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| Name | Class |
|---|---|
| Spastic Paraplegia Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hereditary Spastic Paraplegia | Experimental | Participants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahul Sachdeva, PhD | Contact | 8592574888 | rahulsachdeva@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rahul Sachdeva, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
Deidentified individual participant outcomes data will be published in peer-reviewed journals.
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| ID | Term |
|---|---|
| D015419 | Spastic Paraplegia, Hereditary |
| ID | Term |
|---|---|
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
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| 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,). | 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. | 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. | 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). | Baseline, Weeks 1, 4, 8, and 16 |
| 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. | 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 | Baseline, Weeks 1, 4, 8, and 16 |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |