OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- IBS-related symptoms
研究概览
简要总结
The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.
详细描述
In part 1, data collection for training the OIME model, we will collect autonomic and muscular activities with integrated biosignal device and visceral pain level in both healthy controls and IBS participants. These data will be used to train a machine learning model to produce an objective integrated multimodal electrophysiological (OIME) index.
In part 2, the ambulatory trial, we will collect data to validate the OIME index as a biomarker of pain in IBS participants. We will run an ambulatory trial to validate the OIME index as a biomarker to assess the treatment of IBS pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain.
- •Men and women 18-50 years old
- •Able to read and speak English
- •Daily access to a computer with internet access.
排除标准
- •Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc.
- •Celiac disease or inflammatory bowel disease
- •Diabetes mellitus; d) Serious mental health conditions
- •Women during pregnancy or within 3 months post-partum period
- •Self- reported Regular use of opioids or other illicit substances.
- •Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.
结局指标
主要结局
IBS-related symptoms
时间窗: Baseline and 4-week follow-up; Weekly Online Logs
Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data.
Electrocardiogram (ECG)
时间窗: Baseline and 4-week follow-up
ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Electrodermal activity (EDA)
时间窗: Baseline and 4-week follow-up
EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS
Pain intensity and interference
时间窗: Baseline and 4-week follow-up; Weekly Online Logs
Brief Pain Inventory (BPI) scale: the 9-item scale measures pain intensity and interference using 0 - 10 rating scales. Higher score indicates higher levels of pain intensity and interference.
Electromyogram (EMG)
时间窗: Baseline and 4-week follow-up
EMG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
Objective integrated multimodal electrophysiological index
时间窗: Baseline and 4-week follow-up
Objective integrated multimodal electrophysiological (OIME) index as a biomarker for visceral pain will be generated and validated through integration of surface bio-signal recordings of EDA, ECG, and EMG via a supervised machine-learning algorithm.
次要结局
未报告次要终点
研究者
Hugo Posada-Quintero
Assistant Professor
University of Connecticut