Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Change from baseline of posterior root reflexes (PRRs) recruitment curves.
研究概览
简要总结
People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.
The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.
详细描述
The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes:
- Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz.
- Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen.
- Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine.
- Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone.
Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
The participants and assessors are kept unaware of which intervention is being administered. For this, the study drugs are designed to be visually identical for all participants, and the intervention and sham stimulation configuration is set without the assessor being present in the room.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline of posterior root reflexes (PRRs) recruitment curves.
时间窗: Baseline and at post-intervention (100 minutes)
Change in area under the recruitment curve of PRRs after the intervention compared to the baseline. These reflexes are elicited by transcutaneous spinal stimulation and recorded in key muscles of the lower extremities.
Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
时间窗: Baseline and at post-intervention (100 minutes)
Change in the amplitude of the FWR response after the intervention compared to the baseline. The reflex response indicates neural circuitry function and spasticity in individuals with neurological conditions. It is measured by eliciting a motor response through a standardized electrical stimulus and quantifying the change in muscle activity.
Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),
时间窗: Baseline and at post-intervention (100 minutes)
Change in cumulative scores of Modified Ashworth Scale in bilaterally five lower extremity muscles (score range: 0 to 40, where higher scores denote worsening outcomes) before and after the 30-minute intervention. The Modified Ashworth Scale is a clinically validated tool that measures resistance during passive soft-tissue stretching and indicates spasticity.
Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS).
时间窗: Baseline and at post-intervention (100 minutes)
Change in the cumulative score of the Spinal Cord Assessment Tool for Spastic Reflexes, encompassing clonus, flexor spasms, and extensor spasms bilaterally, with a scoring range from 0 to 18, where higher scores denote worsening outcomes. The Spinal Cord Assessment Tool for Spastic Reflexes is a clinical tool designed to evaluate spastic reflexes in individuals with spinal cord injury specifically. It quantitatively measures the severity and pattern of spasticity by assessing involuntary muscle contractions in response to external stimuli.
Change from baseline of stretch reflex (SR) response amplitude.
时间窗: Baseline and at post-intervention (100 minutes)
Change in the amplitude of the SR response after the intervention compared to the baseline. The reflex response indicates spasticity and muscle tone in participants with neurological disorders. The amplitude of the reflex response reflects the muscle's reaction to stretch.
次要结局
- Change from baseline of flexion withdrawal reflex (FWR) response amplitude.(Baseline and at during transcutaneous spinal stimulation (80 minutes))
- Change from baseline of stretch reflex (SR) response amplitude.(Baseline and at during transcutaneous spinal stimulation (80 minutes))
- Change from baseline of posterior root reflexes (PRRs) recruitment curves.(Baseline and at during transcutaneous spinal stimulation (80 minutes))
研究者
Matthias J. Krenn, PhD
Assistant Professor
University of Mississippi Medical Center