The Biophysical Impact of Transcutaneous Spinal Cord Stimulation Within a Single Session
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Knee extension strength
研究概览
简要总结
To determine the biophysical impact of biophysical Impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. We hypothesize that subjects will demonstrate increased volitional muscle strength with TSCS. This will be assessed by isokinetic strength testing of post-injury dominant-side knee extension. Subjects will be tested in both Transcutaneous Spinal Cord Stimulation and sham conditions.
详细描述
The investigators will conduct isokinetic strength testing (via the Biodex) of post-injury, dominant-side knee extension before, during, and after TSCS and a sham condition. Transcutaneous Spinal Cord Stimulation will be applied (via the Vectra Neo) using a 5cm x10cm oval electrode placed midline on the skin between spinous process T11 -T12 as a cathode and two 7.5cm x 13cm rectangular electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50Hz and 1millisecond, will be used to provide 30 continuous minutes of stimulation. As sham procedures for this intervention have not been established, the investigators will follow sham procedures well documented in Transcranial DC Stimulation (tDCS). Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued. Subjects will participate in two testing sessions, each approximately one hour in length, separated by at least 24 hours.
Subject's starting condition will be randomized. Subjects will be informed that two stimulation conditions are being tested, but will not be told which is the experimental condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 1 year post spinal cord injury
- •Non-progressive spinal cord injury
- •Neurological level above T10
- •Tolerates upright position for >30 minutes
- •Medically stable (no hospitalizations in last 3 months)
- •Unilateral knee extension strength >/= 1/5 MMT
- •Able to comply with procedures and follow up
- •Are legally able to make their own health care decisions
排除标准
- •Progressive SCI/D (MS, ALS, ADEM, etc.)
- •Opens wounds at stimulation site
- •Pregnant women
- •ROM limits of >10 degree of knee flexion or extension
- •Cardiac pacemaker/defibrillator
- •Active cancer diagnosis
- •Currently receiving TSCS
- •Evidence of uncontrolled autonomic dysreflexia
- •Non- English speaking
结局指标
主要结局
Knee extension strength
时间窗: Day 1, Day 2
Change in isokinetic strength assessment of the post-injury dominant side quadripceps
次要结局
未报告次要终点
研究者
Rebecca Martin, OTR/L, OTD
Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.