Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury: an Exploratory, Interventional, Non-randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EEG Spectral Characteristics
研究概览
简要总结
The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65 years old;
- •American Society of Anesthesiologists (ASA) I-III;
- •Dextromanual;
- •Chronic Pain following Spinal Cord Injury;
- •Spinal cord electrical stimulator implantation under general anesthesia;
- •Signed informed consent.
排除标准
- •People with mental and behavioral disorders.
- •Previous history of craniocerebral disease;
- •History of drug and alcohol abuse;
- •Patients with aphasia or inability to cooperate with the pain assessments;
- •Previous adverse reaction to esketamine, opioids or NSAIDs;
- •Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
- •Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
- •Bleeding tendency;
- •BMI ≥ 35 kg/m²;
- •Pregnancy or lactation.
- •Spinal Cord Injury Patients Without Pain
- •Inclusion Criteria:
- •Age 18 - 65 years old;
- •American Society of Anesthesiologists (ASA) I-III;
- •Dextromanual;
- •Spinal Cord Injury Patients Without Pain;
- •Spinal cord electrical stimulator implantation under general anesthesia;
- •Signed informed consent.
- •Exclusion Criteria:
- •People with mental and behavioral disorders.
- •Previous history of craniocerebral disease;
- •History of drug and alcohol abuse;
- •Patients with aphasia or inability to cooperate with the pain assessments;
- •Previous adverse reaction to esketamine, opioids or NSAIDs;
- •Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
- •Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
- •Bleeding tendency;
- •BMI ≥ 35 kg/m²;
- •Pregnancy or lactation.
研究组 & 干预措施
Patients with chronic pain treated with esketamine
干预措施: Spinal Cord Stimulation (Device)
Patients without pain
干预措施: No intervention (Other)
Patients with chronic pain treated with esketamine
干预措施: Esketamine(Continuous infusion) (Drug)
Patients with chronic pain treated with remifentanil
干预措施: Remifentanil (Target-Controlled Infusion) (Drug)
Patients with chronic pain treated with remifentanil
干预措施: Spinal Cord Stimulation (Device)
Patients with chronic pain treated with flurbiprofen
干预措施: Flurbiprofen (Single intravenous injection) (Drug)
Patients with chronic pain treated with flurbiprofen
干预措施: Spinal Cord Stimulation (Device)
结局指标
主要结局
EEG Spectral Characteristics
时间窗: During the trial(up to 3 hours for each subject).
EEG power spectrum characteristics of chronic pain in patients with spinal cord injury under esketamine, remifentanil, flurbiprofen administration and spinal cord stimulation, including the δ, θ, α, β, and γ frequency bands. administration, including the δ, θ, α, β, and γ frequency bands.
次要结局
- Generalized Anxiety Disorder(GAD-7)(During the trial(through study completion, 7 days))
- Patient Health Questionnaire-9(PHQ-9)(During the trial(through study completion, 7 days))
- Numeric Rating Scale(NRS)(During the trial(through study completion, 7 days))
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital