Use of Two DBS Electrodes to Treat Post-Traumatic Tremor

使用两个 DBS 电极治疗创伤后震颤

• 批准号: 7683956
• 负责人: Kelly D Foote
• 金额: $ 16.05万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-04 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7683956
• 关键词: Adverse effects; Aftercare; Anterior; Blinded; Clinical Investigator; Clinical Research; Deep Brain Stimulation; Development; Devices; Electrodes; Evaluation; Fellowship; Future; Implanted Electrodes; Individual; Institution; Lead; Lesion; Medical; Mentored Patient-Oriented Research Career Development Award; Mentorship; Movement Disorders; Multiple Sclerosis; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Pilot Projects; Principal Investigator; Randomized; Recruitment Activity; Refractory; Reporting; Residencies; Safety; Technology; Testing; Time Study; Training; Tremor; design; effective therapy; follow-up; innovation; neurosurgery

DESCRIPTION (provided by applicant): The objective of this K23 Award proposal is to investigate the safety and efficacy of ventralis intermedius (VIM) plus ventralis oralis anterior/ventralis oralis posterior (VOA/VOP) deep brain stimulation (DBS) for the treatment of post-traumatic and multiple sclerosis (MS) tremor. Post-traumatic and MS tremors tend to be markedly disabling and refractory to medical therapy. Lesions and deep brain stimulation have had mixed and somewhat disappointing results. Previously, we reported the use of two DBS electrodes (one at the VIM/VOP border and one at the VOA/VOP border) as effective for the treatment of post-traumatic tremor in a single patient, and have since followed up this case with a larger pilot study in four patients. This study will test the hypothesis that two electrodes are better than one for treatment of post-traumatic and MS tremor. Twenty patients will be recruited and randomized into two groups (VIM versus VOAA/OP). All patients will have two electrodes implanted, however, for the first 3 months of the study half of the patients will have VIM DBS, and half VOAA/OP DBS (only one device activated - patient and examiner blinded). Following this blinded period of evaluation, all patients will have both electrodes activated, and at 6 months will be tested in four randomized conditions: VIM DBS on - VOAA/OP DBS off, VIM DBS off - VOAA/OP DBS on, VIM DBS on - VOAA/OP DBS on, and VIM DBS off - VOAA/OP DBS off. Testing will be performed in the clinical research center (CRC) over four days. The study aims not only to evaluate the effects of dual electrode DBS for the treatment of post-traumatic and MS tremor, but also to investigate the effects of each individual electrode, as well as potential side effects of this therapy. It is hoped that this study will result in more effective treatment of medication refractory post-traumatic and MS tremor, and lead to future R01 proposals aimed at the development of innovative applications of DBS technology. The overall proposal has been carefully designed to support the principal investigator's development as a clinical investigator.

描述（由申请人提供）：本 K23 奖提案的目的是研究中间腹肌 (VIM) 联合口腹前肌/口腹后肌 (VOA/VOP) 深部脑刺激 (DBS) 治疗以下疾病的安全性和有效性：创伤后和多发性硬化症（MS）震颤。外伤后和多发性硬化症震颤往往会导致明显的致残，并且药物治疗难以治愈。损伤和深部脑刺激的结果好坏参半，有些令人失望。此前，我们报道了使用两个 DBS 电极（一个在 VIM/VOP 边界，一个在 VOA/VOP 边界）对治疗一名患者的创伤后震颤有效，并且此后对该病例进行了随访对四名患者进行的更大规模的试点研究。这项研究将验证两个电极比一个电极更适合治疗创伤后和多发性硬化症震颤的假设。将招募 20 名患者并随机分为两组（VIM 组与 VOAA/OP 组）。所有患者都将植入两个电极，但是，在研究的前 3 个月，一半患者将接受 VIM DBS，一半患者将接受 VOAA/OP DBS（仅激活一个设备 - 患者和检查者均处于盲态）。在此盲态评估期之后，所有患者将激活两个电极，并在 6 个月时在四种随机条件下进行测试：VIM DBS 开启 - VOAA/OP DBS 关闭、VIM DBS 关闭 - VOAA/OP DBS 开启、VIM DBS 开启- VOAA/OP DBS 打开，VIM DBS 关闭 - VOAA/OP DBS 关闭。测试将在临床研究中心（CRC）进行四天。该研究的目的不仅是评估双电极 DBS 治疗创伤后和 MS 震颤的效果，还研究每个电极的效果以及该疗法的潜在副作用。希望这项研究能够更有效地治疗难治性创伤后和多发性震颤，并引发未来旨在开发 DBS 技术创新应用的 R01 提案。总体提案经过精心设计，以支持主要研究者作为临床研究者的发展。