Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Average Pain Reduction Post Intervention
研究概览
简要总结
The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a custom-designed virtual reality leg scenario) will lead to controlled analgesia induction, boosting analgesic effects obtained with standard SCS treatments and will further be associated with changes in the perception of the affected body part.
详细描述
Epidural spinal cord stimulation (SCS) is an approved treatment for truncal and extremity neuropathic pain. The mechanisms underlying the efficacy of SCS are unknown. Recent advances in cognitive neuroprosthetics using virtual reality allow for modulation of body perception and bodily experience, which has also been shown to modulate pain perception. The present research proposal plans to merge expertise in cognitive neuroprosthetics with neuromodulation techniques in order to test the analgesic properties of the combination of epidural spinal cord stimulation with a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation). The investigators propose to study this hypothesis prospectively in 25 patients with implanted SCS systems for the treatment of chronic neuropathic pain. Primary outcomes will be pain reduction (based on subjective, functional and physiological measures) and changes in body perception (based on subjective and objective measures). The present study will generate a proof-of-concept for the application of neuro-visual stimulation for the treatment of chronic pain and will form the basis for future NIH funding application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 18-and older at the time of enrollment
- •Patients carrying a diagnosis of CPRS type 125 or chronic refractory neuropathic leg pain following FBS4
- •Patients who have implanted epidural SCS
- •The SCS implantation for at least three months prior to enrollment
- •Patients with efficacious SCS as defined by ≥ 50% pain improvement after switching SCS from an OFF state to an ON state ('optimal' stimulation efficacy)
- •Patients willing and able to provide informed consent
排除标准
- •Patients who are unable to effectively or efficiently communicate for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.
- •Patients with history of prior cranial surgery, significant brain lesions for example intracranial tumors, strokes etc.
- •Non efficacious response to SCS <50% pain improvement with optimal stimulation parameters
- •Evidence of untreated psychiatric disorders or drugs/alcohol abuse.
- •History of seizures
结局指标
主要结局
Average Pain Reduction Post Intervention
时间窗: At each hour from 1-5 hours post intervention
10 point Visual Analog pain rating Scale. Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients rate their pain, ranging from "no pain" (bottom part of the scale) to "the worst imaginable pain" (upper part of the scale) (Huskisson 1974). The pain reduction will be an average total of the pain scores taken at hours 1, 2, 3, 4, and 5.
次要结局
- Pain Reduction Base on Patient Perception(per minute in each virtual reality condition for 10 minutes in each reality condition.)
研究者
Vibhor Krishna
Assistant Clinical Professor
Ohio State University