Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Patient Tolerance of Device
研究概览
简要总结
This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR and Neurofeedback training and their pain will be assessed.
详细描述
QUASAR and UCSD are conducting a clinical trial on 25 subjects to evaluate the feasibility of a novel Neurofeedback electroencephalography (EEG) Virtual Reality (VR) system aimed at reducing chronic pain. The NEVR device consists of a dry electrode EEG headset combined with a VR Head-Mounted Display (VR-HMD) device and neurofeedback software. This approach relies on retraining the brain's networks to reduce the perception of pain and does not involve pharmaceutical drugs. Patients with chronic lower back pain will be recruited by UCSD at its Altman Clinical & Translational Research Institute. Patients that meet the recruitment criteria will be asked to conduct 20 1-hour long sessions of EEG-based Neurofeedback in VR over the course of a couple of months. Pain assessment and device usability questionnaires will be conducted prior to and after the first and last sessions, and at intermediate time points. This will be a single arm clinical trial aimed at demonstrating the safety and viability of the NEVR device, with the primary outcome measure being the ability of patients to conduct all 20 sessions safely and comfortably. Secondary outcome measures include assessment of changes in pain perception, and of changes in EEG activity patterns.
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
- 17 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic back pain that can be of multifactorial etiology inclusive of axial and radicular back pain
- •Report a Numerical Rating Scale (NRS, or Visual Analog Score VAS) score of greater than 6/10
- •Must be willing to for the duration of the study make no pharmacological adjustments or have additional Interventional therapies, as reported by the patient
- •Must have the cognitive capacity to provide consent/assent
- •Must be able to sit up in a chair during the recording session
- •Must demonstrate understanding of the protocol, its purpose and subject participation
- •Must be fluent in English
排除标准
- •Measured head size too small or too large for the EEG equipment
- •Any significant skull defect
- •History of a recent craniotomy (within the last six months)
- •Any signs of scalp inflammation, irritation, or abnormal skin conditions
- •History of epilepsy or seizures
- •Known allergies to any material to be used in this project
- •Sight disabilities that make participation impractical
- •Hair styles with thick braids or dread locks
研究组 & 干预措施
Single
Single group to receive intervention
干预措施: NEVR (Device)
结局指标
主要结局
Patient Tolerance of Device
时间窗: up to 6 months
The researchers will survey the subjects about their comfort of wearing the device after each session on a scale of 1-10, where 1 is intolerable, 5 is just tolerable, and 10 is most comfortable. The researchers refer to this as the Comfort Scale.
Adverse Effect on Pain
时间窗: up to 6 months
Subjects' back pain will be assessed prior to and after the first, 10th and last sessions via the following standardized subjective, objective, behavioral and functional evaluation tests: 1) Numerical Rating Scale (NRS, or Visual Analog Pain Score (VAS), 2) The DALLAS scale; 3) Patient Assessment Global Change. The researchers will compare the before and after session results to determine if the sessions had a negative impact on the patients' perceived pain.
Percent of Patients Completing the Study
时间窗: up to 6 months
The researchers will calculate the percentage of patients who complete all 20 sessions of the study without any adverse effects nor any discomfort from the device or VR.
Patient Tolerance of Device
时间窗: up to 6 months
The researchers will survey the subjects about their comfort of wearing the device after each session on a scale of 1-10, where 1 is intolerable, 5 is just tolerable, and 10 is most comfortable. The researchers refer to this as the Comfort Scale.
Adverse Effect on Pain
时间窗: up to 6 months
Subjects' back pain will be assessed prior to and after the first, 10th and last sessions via the following standardized subjective, objective, behavioral and functional evaluation tests: 1) Numerical Rating Scale (NRS, or Visual Analog Pain Score (VAS), 2) The DALLAS scale; 3) Patient Assessment Global Change. The researchers will compare the before and after session results to determine if the sessions had a negative impact on the patients' perceived pain.
次要结局
- Changes in Pain Perception(6 months)
- Dose Response(up to 6 months)
- Signal Quality(up to 6 months)
- Changes in Pain Perception(6 months)
- Changes in EEG Activity Patterns(up to 6 months)
- Dose Response(up to 6 months)
- Signal Quality(up to 6 months)