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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究旨在测试电刺激额叶区域的大脑表面是否有助于治疗抑郁症状。电刺激包括通过外科手术将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(EPC)，并使用Intrel设备(美敦力公司)。 这项研究涉及首次研究，以获得关于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)已批准该系统植入慢性疼痛患者的脊髓，但其使用仍在调查中，该手术仍处于试验阶段，适用于患有抑郁症的患者。这项研究是人类首次使用Intrel设备(美敦力公司)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。这项研究计划招募最多15名患者，其中5名将植入内皮祖细胞，5名将进行为期1年的自然随访。

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.