A staged, comprehensive investigation for developing insular deep brain stimulation to treat refractory chronic pain

开发岛叶深部脑刺激治疗难治性慢性疼痛的分阶段综合研究

• 批准号: 10437978
• 负责人: William Jeffrey Elias
• 金额: $ 105.6万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10437978
• 关键词: Acute; Address; Adverse effects; Affective; Analgesics; Anterior; Attenuated; Bilateral; Biological Markers; Biotechnology; Brain; Brain Mapping; Cerebrum; Chronic; Clinical; Clinical Trials; Cognitive; Complex; Conscious; Cutaneous; Data; Deep Brain Stimulation; Development; Diffusion; Dose; Double-Blind Method; Electric Stimulation; Electrocardiogram; Electrodes; Electroencephalography; Electrophysiology (science); Enrollment; Epilepsy; Evidence based treatment; Financial Hardship; Home environment; Human; Implant; Inpatients; Insula of Reil; Interruption; Investigation; Lasers; Location; Magnetic Resonance Imaging; Maps; Measures; Methods; Monitor; Motivation; Movement Disorders; Nociception; Nonpharmacologic Therapy; Opiate Addiction; Opioid; Outcome Measure; Pain; Pain intensity; Patients; Pharmacology; Procedures; Process; Randomized; Refractory; Reporting; Research; Safety; Seizures; Sensory; Severities; Site; System; Translating; adverse event monitoring; base; chronic neuropathic pain; chronic pain; chronic pain management; chronic pain patient; chronic pain relief; clinical pain; design; experience; improved; insight; neuroimaging; neurophysiology; neuroregulation; novel; novel diagnostics; pain perception; pain reduction; pain relief; pain signal; painful neuropathy; primary outcome; prognostic; relating to nervous system; response; secondary outcome; side effect

PROJECT SUMMARY Patients with refractory chronic pain typically do not respond to traditional analgesics or weak opioids as these agents do not directly address the cause for their pain. Many chronic pain patients do not achieve satisfactory pain relief even with evidence-based treatment, or they do not tolerate effective doses because of adverse side effects. Deep brain stimulation (DBS) is already an established treatment for intractable movement disorders and epilepsy, and recent advancements in the fields of pain neurophysiology and biotechnology may facilitate the use of DBS as a nonpharmacological therapy for refractory chronic pain. In the first stage of the proposed project, we will enroll 12 subjects with refractory neuropathic pain to an inpatient clinical trial for insular brain mapping with acute stimulation and neurophysiological brain monitoring. Electrodes for stimulating and recording will be implanted stereotactically along the anterior-posterior axis of the insular cortex. Subjects with positive analgesic effects during acute insular stimulation in the first stage of the proposed project will continue to the second stage, which will consist of a randomized, sham-stimulation-controlled, double-blinded, cross-over clinical trial of chronic insular DBS with the purpose of obtaining safety and efficacy data for this procedure. Furthermore, we aim to develop neurophysiological biomarkers of pain by studying changes in neural activity. Safety data, effect size, and insular stimulation parameters obtained from this research will be used in the design of subsequent clinical trials. The neurophysiological pain biomarkers identified in this project will also aid the development of a novel, closed-loop insular DBS system, as well as new diagnostic/prognostic measures for managing chronic pain. If proven to be safe and effective, insular DBS will offer a much needed non-pharmacological treatment option for patients suffering from refractory chronic pain.

项目总结