Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Barrow Neurological Institute (BNI) pain score changes
研究概览
简要总结
Trigeminal neuralgia (TN) is the most common cause of facial pain. Medical treatment is the first therapeutic choice whereas surgery, including Gamma Knife radiosurgery (GKRS), is indicated in case of pharmacological therapy failure. However, about 20% of subjects lack adequate pain relief after surgery. Virtual reality (VR) technology has been explored as a novel tool for reducing pain perception and might be the breakthrough in treatment-resistant cases. The investigators will conduct a prospective randomized comparative study to detect the effectiveness of GKRS aided by VR-training vs GKRS alone in TN patients. In addition, using MRI and artificial intelligence (AI), the investigators will identify pre-treatment abnormalities of central nervous system circuits associated with pain to predict response to treatment. The investigators expect that brain-based biomarkers, with clinical features, will provide key information in the personalization of treatment options and bring a huge impact in the management and understanding of pain in TN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physiotherapist, neurologists, neuropsychologists, radiologist and biomedical engineering assessing the patients are blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of TN according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria;
- •age >18 years;
- •indication to undergo radiosurgical treatment;
- •willingness and ability to comply with scheduled visits and other trial procedures.
排除标准
- •Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated;
- •metal implants, pacemaker, etc.;
- •Pregnancy or breastfeeding;
- •Any significant psychiatric disease;
- •Use of illicit drugs;
- •Brain pathology shown by brain MRI and/or neurophysiological examination;
- •Any person unable to understand and follow the instructions of the investigators;
- •Any other condition according to the Investigator would make the subject unsuitable for the study.
结局指标
主要结局
Barrow Neurological Institute (BNI) pain score changes
时间窗: Baseline, month 3 and month 12
Changes in time in the Barrow Neurological Institute (BNI) pain intensity scale to assess the level of pain in patients with trigeminal neuralgia. BNI values I-III were considered to indicate good outcomes whereas BNI values IV and V indicate poor response to treatment.
Numeric Rating Scale for pain (NRS) changes
时间窗: Baseline, month 3 and month 12
Changes in time in the Numeric rating scale (NRS): a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
次要结局
- McGill Pain Questionnaire (MPQ) changes(Baseline, month 3 and month 12)
- Penn Facial Pain Scale (PFPS) changes(Baseline, month 3 and month 12)
- Longitudinal changes of brain gray matter volumes(Baseline, month 3 and month 12)
- Resting-State Functional Connectivity MRI changes(Baseline, month 3 and month 12)
- 12-item Allodynia Symptom Checklist (ASC-12) scale changes(Baseline, month 3 and month 12)
- Longitudinal changes of white matter microstructural abnormalities(Baseline, month 3 and month 12)
- Pain Catastrophizing Scale (PCS)(Baseline, month 3 and month 12)
- Craniofacial Pain and Disability Inventory (CFPDI) changes(Baseline, month 3 and month 12)
- Percentage of displacement of virtual face landmarks(Baseline, month 3 and month 12)
- Functional MRI changes(Baseline, month 3 and month 12)
- Central Sensitization Inventory (CSI) changes(Baseline, month 3 and month 12)
- Tampa Scale of Kinesiophobia (TSK) changes(Baseline, month 3 and month 12)
- Trigeminal reflexes testing(Baseline, month 3 and month 12)
研究者
Prof. Massimo Filippi
Prof.
IRCCS San Raffaele