Machine-Learning Based EEG Biomarkers for Personalized Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Patient Improvement as assessed by a composite score
研究概览
简要总结
The goal of this observational study is to develop a machine learning model to predict the outcome of a transcranial direct current stimulation (tDCS) treatment in patients suffering from neuropathic pain derived from a spinal cord injury. The main question it aims to answer is:
• Can electroencephalography (EEG) and clinical assessment data predict the success of tDCS treatment in neuropathic pain patients?
Participants will:
- Undergo EEG recording sessions to collect brain activity data before treatment.
- Complete clinical assessments, including medical diagnostics and questionnaires focused on factors related to neuropathic pain before and after treatment.
详细描述
This project aims to develop an artificial intelligence model to predict the response to a neuromodulation treatment (transcranial Direct Current Stimulation, tDCS) for neuropathic pain (NP) following spinal cord injury (SCI), based on electroencephalographic (EEG) signals and clinical assessments. The project consists of two stages:
Stage 1 involves an open trial where participants with SCI and NP will receive neuromodulation treatment at our center, with data collected before and after treatment.
Pre-Treatment Evaluation:
- Clinical assessment through interviews and validated questionnaires targeted at factors associated with neuropathic pain, depression, and other relevant components.
- EEG recording using a 64-channel device (Brain Products GmbH, Germany). EEG will be recorded in a soundproof room with participants in a resting state, first with eyes open for 5 minutes and then with eyes closed for another 5 minutes. Participants will be asked to avoid alcohol 12 hours prior and caffeine 3 hours before the recording.
Neuromodulation Treatment:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Over 18 years old.
- •Neuropathic Pain (NP): Subacute NP at or below the lesion level for at least 1 month following spinal cord injury or disease. Persistent NP is defined as pain in an area of sensory abnormality corresponding to the spinal cord injury according to international criteria (Bryce et al. 2012). The pain should not be primarily related to spasms or any other movement.
- •Pain Intensity: At least 4 out of 10 on the Numerical Rating Scale (NRS) at the time of screening (rated during the previous 24 hours).
- •Pharmacological Treatment: Stable treatment including antiepileptic, antidepressant, or antispastic drugs (Gabapentin (GBP) with a minimum dose of 900 mg/day, Pregabalin (PGB) with a minimum dose of 150 mg/day, Amitriptyline with a minimum dose of 25 mg/day). No dose changes for at least 2 weeks prior to treatment and no additional antiepileptic medication. The pharmacological regimen must be maintained without changes during the 10-day stimulation period and until the electrophysiological measurement. It is recommended to keep the regimen stable until the completion of the following two evaluations (4 and 12 weeks after the end of treatment). Only paracetamol or anti-inflammatory drugs are allowed as rescue treatment.
排除标准
- •Patients with severe pain (NRS > 7) from other sources, such as musculoskeletal pain, inflammatory pain, or cancer-related pain.
- •Subjects with traumatic brain injury.
- •Subjects with alcohol abuse.
- •Subjects with neurological diseases other than the specified spinal cord injury.
- •Subjects with substance abuse.
- •Subjects with any other chronic medical condition where transcranial tDCS is relatively contraindicated, such as pregnancy or epilepsy.
结局指标
主要结局
Patient Improvement as assessed by a composite score
时间窗: After tDCS treatment (compared to score before tDCS treatment)
Composite Score Breakdown: Neuropathic Pain Symptom Inventory (NPSI) Items: * Constant pain intensity: Questions 1, 2, 3, 11, 12 (sum) * Constant pain persistence/frequency: Question 4 * Pain crisis intensity: Questions 5, 6 (sum) * Pain crisis frequency: Question 7 * Allodynia: Questions 8, 9, 10 (sum) Criteria: * Numerical NPSI items are only used where pre-treatment pain ratings are 4/10 or higher. * Responder: Any NPSI item shows a 50% or larger reduction. Brief Pain Inventory (BPI) Items: * Pain Interference: Questions 3a - 3g (average) Criteria: * Responder: 30% improvement or more. Summary: A subject is considered a responder if BOTH of these conditions are met: 1. Improvement of 50% or more in pain intensity or frequency (NPSI). 2. Improvement of 30% or more in pain interference (BPI).
次要结局
未报告次要终点
研究者
Dolors Soler
PhD, Principal Investigator
Institut Guttmann