Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PainQx, Inc
- 入组人数
- 334
- 试验地点
- 4
- 主要终点
- Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State
研究概览
简要总结
PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people with chronic pain and 50 healthy controls in order to develop algorithms that will objectively assess the level of pain a person is experiencing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female chronic pain patients
- •Patients between the ages of 18-85 years
- •Patients exhibiting the presence of symptoms in excess of 3 months duration
- •Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
- •Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)
- •Patients with NRS pain scores across the full range (1-10) at the time of testing Inclusion Criteria, Normal (no-pain) Group
- •o Subjects will be included with no history of pain with a duration of greater than 3 months, and no report of pain at the time of testing (or within 3 months of testing)
排除标准
- •Patients with medically diagnosed psychotic illness
- •Patients with medically diagnosed drug or alcohol dependence in the past 12 months
- •Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
- •Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
- •Patients who have a spinal cord stimulator, or other implantable devices
- •Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain
- •Note: This does not exclude patients who suffer from these disorders if the current source of pain is not due to the disorder. For example, patients with diabetes are NOT excluded, but patients whose pain at the time of the evaluation is a result of diabetic neuropathy are excluded. Similarly, patients with a history of migraines but for whom a migraine is not the current source of pain at the time of the evaluation are NOT excluded.
- •Patients with cancer
- •Patients on workers compensation or disability
- •Patient on anticonvulsant medication
- •Patients who have a history of seizures
结局指标
主要结局
Area Under the Curve of Classification Versus Patient Self Report of Pain vs no Pain State
时间窗: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
This measure is the performance of the classification of pain vs no pain compared to the patient self-report in the form of Numerical Rating Scale (NRS). The primary outcome measure is Area Under the Curve (AUC), derived from the Receiver Operating Characteristic (ROC) curve, a standard metric of performance for binary classifiers. AUC is a numeric quantity ranging from 0 to 1, where the value of 1 indicates perfect separation, while 0.5 represents zero separation. AUC represents a fundamental expression of classifier separation performance without the complexity of threshold selection. (NRS 0 vs 1-10)
Sensitivity of Classification Versus Patient Self Report of Pain vs no Pain State
时间窗: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Sensitivity, or true positive rate is the probability of a positive result in the true chronic pain patients. This measure is calculated by dividing true positives by the summation of true positives and false negatives. (NRS 0 vs 1-10)
Specificity of Classification Versus Patient Self Report of Pain vs no Pain State
时间窗: Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.
Specificity, or true negative rate is the probability of a negative result in the true healthy control patients. This measure is calculated by dividing true negatives by the summation of true negatives and false positives. (NRS 0 vs 1-10)
次要结局
- Area Under the Curve of Classification Versus Patient Self Report of no/Mild Pain vs Moderate/Severe Pain State(Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.)
- Area Under the Curve of Classification Versus Patient Self Report of no, Mild, or Moderate Pain vs Severe Pain State(Self-reported pain using average of NRS value at the start and end of EEG collection, and classification based on 15 minutes of EEG collection.)