NCT06559735招募中不适用
A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Numerical Pain Rating Scale (NRS)
研究概览
简要总结
The primary objective of the study is to determine changes in cerebral nociceptive hemodynamic response (blood oxygenation/flow) before, during and following spinal cord stimulation (SCS). Objective measurements of cerebral nociceptive hemodynamic responses will be obtained with the CereVu sensor and ROPA system and will be analyzed offline and compared against subjective measures of pain. Proprietary analysis algorithms will be incorporated and developed to understand how the objective measurements correlate with subject reported pain levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Be 18 years of age or older at the time of enrolment
- •Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months
- •Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS)
- •Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements, procedures, and visits
排除标准
- •Subject is pregnant or nursing
- •Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
- •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes
- •Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
- •Have prior experience with SCS
- •Be concomitantly participating in another clinical study
- •Subject has secondary gain issues that could interfere with the study measures or outcomes
- •Subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. Non-intact skin on the forehead, or ENT surgery)
- •Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor
结局指标
主要结局
Numerical Pain Rating Scale (NRS)
时间窗: 1 week
Subjective pain 11-point pain scale
Regional Cerebral Oxygenation/Blood Flow
时间窗: 1 week
Opital Spectophotometry measurement from the forehead
次要结局
- Stress/Anxiety(1 week)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Neurologic Evaluation of Patients After Transapical Beating-Heart Septal MyectomyHypertrophic Obstructive Cardiomyopathy \(HOCM\)Neurologic EvaluationMagnetic Resonance Imaging \(MRI\)Transapical Beating-Heart Septal MyectomyCardiac Surgery Involving Left Heart OperationNCT06078410Xiang Wei50
Enrolling By Invitation
不适用
Non-invasive Modulation of Spinal Cord Nociceptive ReflexesPainNCT05711498Max Planck Research Group Pain Perception40
尚未招募
不适用
Consciousness and Nociception During AnesthesiaNociceptive PainAnesthesiaNCT05879731Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal30
尚未招募
不适用
Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement SurgeryCentral SensitisationPostoperative PainArthritisNCT06553118Istanbul University80
已完成
不适用
Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of MalnutritionStuntingSevere Acute MalnutritionWastingNCT05891457International Centre for Diarrhoeal Disease Research, Bangladesh128