A PILOT SAFETY AND EFFICACY STUDY OF EPIDURAL PREFRONTAL CORTICAL STIMULATION

硬膜外前额皮质刺激的试点安全性和有效性研究

• 批准号: 7719603
• 负责人: Ziad Nahas
• 金额: $ 0.89万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719603
• 关键词: Brain; Computer Retrieval of Information on Scientific Projects Database; Devices; Effectiveness; Electric Stimulation; Enrollment; Food; Funding; Grant; Human; Implant; Institution; Mental Depression; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Research; Research Personnel; Resources; Safety; Schizophrenia; Source; Spinal Cord; Surface; System; Testing; Time; United States National Institutes of Health; chronic pain; depressive symptoms; design

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. The electrical stimulation involves surgically placing the electric leads over the surface of the brain. This type of stimulation is referred to as Epidural Prefrontal Cortical Stimulation (EpCS) and uses Intrel Device (Medtronic, Inc.). This study involves first time research to obtain information about the safety and effectiveness of the EpCS for the treatment of depression. Although the U.S. Food and Drug Association (FDA) has approved the system to be implanted over the spinal cord for patients with chronic pain, its use is still investigational and the surgery is still experimental for patients who have depression. This study represents the first human use of the Intrel Device (Medtronic, Inc.) for the treatment of depression. The National Alliance for Research in Schizophrenia and Depression known as NARSAD sponsors this research. This study plans to enroll up to 15 patients, of whom 5 will be implanted with EpCS and 5 will be followed naturalistically for 1 year.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究旨在测试额叶区域大脑表面的电刺激是否将有助于治疗抑郁症状。电刺激涉及将电线放置在大脑表面上。这种类型的刺激称为硬膜外前额叶皮质刺激（EPCS），并使用Intrel设备（Medtronic，Inc。）。 这项研究涉及第一次研究，以获取有关EPC治疗抑郁症的安全性和有效性的信息。尽管美国食品和药物协会（FDA）已批准该系统植入脊髓上的慢性疼痛患者，但其使用仍在研究中，并且该手术对于患有抑郁症的患者仍是实验性的。这项研究代表了内部装置（Medtronic，Inc。）的首次使用用于治疗抑郁症。 国家精神分裂症和抑郁症研究联盟（Narsad）赞助了这项研究。 这项研究计划注册多达15名患者，其中5例将植入EPC，其中5例将自然而然地遵循1年。