Sensory Responses to Dorsal Root Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Location of evoked sensory percepts
研究概览
简要总结
The goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. Patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. Investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. Invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.
详细描述
For this study, investigators aim to determine whether DRG and spinal root stimulation might be viable techniques for restoring feedback. Investigators will focus on patients undergoing temporary percutaneous trials of DRG or lateral spinal cord stimulation with leads manufactured by either Boston Scientific (under PMA P030017) or St. Jude (under PMA P150004), which have FDA premarket approval for the management of chronic pain in the trunk and lower limbs. In this early experiment, investigators will not focus on individuals with limb loss, but rather will include patients already undergoing a percutaneous trial of DRG or spinal root stimulation to treat pain. Investigators will characterize the location, modality, and intensity of sensations evoked in the hands or feet with stimulation delivered by an external stimulator.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between the ages of 18 and 70 years old.
- •Subjects must be undergoing an epidural spinal cord implanted electrode array clinical trial with Dr. Helm for the management of pain.
- •Persons must understand the consent and the procedures.
排除标准
- •Persons with open wounds;
- •Persons with implanted metal rods in the spine or limbs;
- •Persons with defibrillator or pacemaker;
- •Persons with permanent skin metal tags or decorations.
结局指标
主要结局
Location of evoked sensory percepts
时间窗: up to 2 days
Document where on the body the subject perceives the stimulation locations.
Stimulation neurophysiology thresholds to stimulus parameters
时间窗: up to 2 days
Quantify the threshold stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation
Stimulation perceptual thresholds to stimulus parameters
时间窗: up to 2 days
Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.
次要结局
- Qualitative self-report of evoked sensations(up to 2 days)
研究者
Lee Fisher, PhD
Assistant Professor
University of Pittsburgh