ECoG BMI for Motor and Speech Control
赞助:
University of California, San Francisco
合作者:
信息的提供 (责任方):
Karunesh Ganguly，University of California, San Francisco
| 追踪信息 | |||
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| 首次提交日期 ICMJE | August 21, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | August 15, 2018 | ||
| 预计主要完成日期 | August 15, 2024 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability][ Time Frame: Up to 6 years post-implant period ] The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | ECoG BMI for Motor and Speech Control | ||
| 正式标题 ICMJE | A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control | ||
| 简要概况 | Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders. |
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| 详细说明 | ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With this ECoG-based neural interface, study patients will undergo training and assessment of their ability to control a wearable hand robotic exoskeleton and determine if ECoG brain signals can be used to produce speech. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Device Feasibility |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
8 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 15, 2030 | ||
| 预计主要完成日期 | August 15, 2024 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Age > 21 2. Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy. 3. Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living. 4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms 5. Must live within a two-hour drive of UCSF Exclusion Criteria: 1. Pregnancy or breastfeeding 2. Inability to understand and/or read English 3. Inability to give consent 4. Dementia, based on history, physical exam, and MMSE 5. Active depression (BDI > 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.) 6. History of suicide attempt or suicidal ideation 7. History of substance abuse 8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure 9. Inability to comply with study follow-up visits 10. Any prior intracranial surgery 11. History of seizures 12. Immunocompromised 13. Has an active infection 14. Has a CSF drainage system or an active CSF leak 15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition 16. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump, or presence of any head or neck metallic foreign bodies 17. Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum iridium, nichrome) | ||
| 性别 |
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| 年龄 | 最小年龄：21 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | Karunesh Ganguly，University of California, San Francisco | ||
| 研究赞助商 ICMJE | University of California, San Francisco | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of California, San Francisco | ||
| 验证日期 | August 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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