Transcranial focused ultrasound for head and neck cancer pain. A pilot study

经颅聚焦超声治疗头颈癌疼痛。

• 批准号: 9899660
• 负责人: William Jeffrey Elias
• 金额: $ 73.19万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9899660
• 关键词: Ablation; Absence of pain sensation; Acute; Acute Pain; Affect; Affective; Anatomy; Area; Binding; Brain; Brain Stem; Cancer Etiology; Cancer Patient; Clinical; Clinical Trials; Cognitive; Devices; Disease; Dose; Effectiveness; Electroencephalography; Electrophysiology (science); Essential Tremor; Evoked Potentials; FDA approved; Focused Ultrasound; Frequencies; Fright; Head and Neck Cancer; High Prevalence; Human; Lasers; Magnetic Resonance Imaging; Malignant Neoplasms; Measures; Medial; Medical; Medication Management; Midbrain structure; Modality; Movement Disorders; Nervous system structure; Neurology; Nociception; Oncologist; Operative Surgical Procedures; Ophthalmology; Opioid; Opioid Receptor Binding; Outcome; Pain; Pain management; Parkinson Disease; Pathway interactions; Patients; Periodicity; Pilot Projects; Positron-Emission Tomography; Procedures; Psychometrics; Quality of life; Refractory; Resistance; Safety; Spinothalamic Tracts; Surgical incisions; Symptoms; System; Thalamic structure; adverse event monitoring; burden of illness; cancer pain; carfentanil; chronic pain; cranium; endogenous opioids; experience; head and neck cancer patient; implantable device; implantation; innovation; midbrain central gray substance; minimally invasive; mortality; mu opioid receptors; new technology; pain relief; painful neuropathy; prescription opioid; relating to nervous system; response; side effect; transmission process

PROJECT SUMMARY Head and neck cancer is particularly susceptible to nocioceptive and neuropathic pains because it is dense with sensitive anatomic structures and richly innervated by the nervous system. In fact, head and neck cancer, estimated as the ninth most common cancer and cause of cancer mortality, is associated with the highest prevalence of pain. These craniocervical pains are particularly difficult for three reasons. Firstly, medical therapy often wanes in effect and/or high doses are required with cognitive side effects. Secondly, surgical options are limited by the cephalad extent in the neural axis. Lastly, cancer and its terminal stages are difficult for invasive surgery or implanted devices that require intensive management. Patients and their oncologists seek pain relief that is easy, safe, and without cognitive side effects. Transcranial MRI-guided focused ultrasound (FUS) is a new stereotactic modality capable of delivering high intensity energy through the intact human skull with submillimeter precision. Our initial experience with FUS targeted the ventrolateral thalamus for essential tremor and Parkinson’s disease, eventually leading to FDA approvals. Cancer pain is an ideal indication to consider stereotactic ablation as the disease burden limits the options. A minimally invasive, transcranial option to treat refractory cancer pain would be welcomed by patients – avoiding opioid medications, open surgery, and device implantation. This exploratory clinical trial (already approved by the FDA under IDE#G180222) will target both the spinothalamic and spinoreticular pain circuits by performing unilateral FUS mesencephalotomy, a historically effective procedure for cancer pain but limited by the accuracy of its era. The primary aim of this study is to assess the safety and preliminary effectiveness in six head and neck cancer patients with opioid-resistant pain. Additionally, we will investigate the potential mechanism of pain relief as the mesencephalotomy target involves the confluence of the ascending and descending pain systems. Aims 2 and 3 will investigate these systems with electrophysiology specific for the spinothalamic tract and carfentanil PET imaging that measures the brain’s endogenous opioids.

项目概要 头颈癌特别容易受到伤害性疼痛和神经性疼痛的影响 因为它富含敏感的解剖结构，并且受到丰富的神经支配 事实上，头颈癌估计是第九大常见癌症。 癌症和癌症死亡的原因，与疼痛的最高患病率相关。 由于三个原因，这些颅颈疼痛特别困难。 治疗效果通常会减弱和/或需要高剂量且会产生认知副作用。 其次，手术选择受到神经轴头侧范围的限制。 癌症及其末期对于侵入性手术或植入装置来说是困难的 患者和他们的肿瘤科医生寻求简单的疼痛缓解， 安全，并且没有认知副作用。 经颅 MRI 引导聚焦超声 (FUS) 是一种新的立体定向模式 能够通过完整的人类头骨传递高强度能量 我们最初使用 FUS 的经验是针对腹外侧的。 丘脑治疗原发性震颤和帕金森病，最终获得 FDA 批准 癌症疼痛是考虑立体定向消融的理想适应症。 疾病负担限制了微创、经颅治疗的选择。 难治性癌症疼痛将受到患者的欢迎——避免使用阿片类药物， 开放手术和装置植入。 这项探索性临床试验（已获得 FDA IDE#G180222 批准）将 通过执行单侧 FUS 来针对脊髓丘脑和脊髓网状疼痛回路 中脑切开术，一种历史上有效的治疗癌症疼痛的手术，但受到以下因素的限制 本研究的主要目的是评估其安全性和初步性。 对六名患有阿片类药物耐药性疼痛的头颈癌患者有效。 此外，我们将研究缓解疼痛的潜在机制 中脑切开术目标涉及上升和下降疼痛的汇合 目标 2 和 3 将通过特定的电生理学研究这些系统。 脊髓丘脑束和卡芬太尼 PET 成像可测量大脑的 内源性阿片类药物。