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.

项目总结