Control of Incomplete Spinal Cord Injury-Related Spasticity by Means of Vibrotactile Coordinated Reset Fingertip Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks.
研究概览
简要总结
The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study.
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
- •Age at the time of enrollment: Any adult ages 18 and over
- •Spinal Cord Injury: ASIA C or D injury at level C1-T1
- •Duration of incomplete spinal cord injury minimum 1 years clinical/fundamental
- •Spasticity with a of MAS score >3 present in upper extremities.
- •Fluent in English
- •If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording.
- •Appropriate social support if required during an off-medication state.
- •Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
- •Feels comfortable going off certain spasticity related medication during in-person study visits
- •Lives in the United States
排除标准
- •Sensory deficits in palma manus resulting in missing inter digit discrimination of the fingertips.
- •Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
- •Any current drug or alcohol abuse.
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- •Pregnancy, breast-feeding or wanting to become pregnant.
- •Physical limitations unrelated to spasticity that would affect motor ratings.
- •Brain surgery
- •Patient is unable to communicate properly with staff (i.e., severe speech problems)
- •Medications that may affect relevant synaptic plasticity
- •Concurrent Botox treatment
- •A type of hairstyle that would impede the use of an EEG cap.
结局指标
主要结局
Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks.
时间窗: Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks
The MAS is a method of grading muscle spasticity according to a 6-point ordinal scale. In this assessment, spasticity is judged to be present when resistance is encountered during passive muscle stretching. With a score of 0 indicating no increase in muscle flexion and a score on 4 indicating and increase in muscle flexion. Low numeric ratings indicate better outcomes and high numbers indicate worse outcome.
次要结局
未报告次要终点
研究者
Peter Tass, MD, PhD
Protocol Director
Stanford University