A PILOT SAFETY AND EFFICACY STUDY OF EPIDURAL PREFRONTAL CORTICAL STIMULATION

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项研究的目的是测试大脑额叶区域表面的电刺激是否有助于治疗抑郁症状。电刺激包括通过外科手术将电导线放置在大脑表面。这种类型的刺激被称为硬膜外前额叶皮质刺激（EpCS），并使用Intrel器械（Medtronic，Inc.）。 本研究首次研究了EpCS治疗抑郁症的安全性和有效性。尽管美国食品和药物协会（FDA）已经批准将该系统植入慢性疼痛患者的脊髓，但其使用仍在研究中，并且该手术仍在抑郁症患者的实验中。本研究代表Intrel器械（Medtronic，Inc.）的首次人体使用。用于治疗抑郁症。 全国精神分裂症和抑郁症研究联盟（NARSAD）赞助了这项研究。 本研究计划入组最多15例患者，其中5例将植入EpCS，5例将自然随访1年。

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.