Noninvasive Spinal Cord Neuromodulation to Enhance Motor Function in Individuals With Hereditary Spastic Paraplegia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in 10-Meter Walk Test (10MWT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Participants with Hereditary Spastic Paraplegia
Participants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks
干预措施: transcutaneous spinal cord stimulation (Device)
结局指标
主要结局
Change in 10-Meter Walk Test (10MWT)
时间窗: Baseline, Weeks 1, 4, 8, and 16
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
Change in 6- Minute Walk Test (6MWT)
时间窗: Baseline, Weeks 1, 4, 8 and 16
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.
Change in Modified Ashworth Scale (MAS)
时间窗: Baseline, Weeks 1, 4, 8, and 16
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
Change in Spastic Paraplegia Rating Scale (SPRS)
时间窗: Baseline, Weeks 1, 4, 8, and 16
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.
次要结局
- Change in Joint Kinematics via Three-dimensional (3D) gait analysis(Baseline, Weeks 1, 4, 8, and 16)
- Change in HSP- Self Notion and Perception (HSP-SNAP) questionnaire(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)
研究者
Rahul Sachdeva
Assistant Professor
University of Kentucky