A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- NIDCD Primary Objective 1
研究概览
简要总结
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
详细描述
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 complex robotic system and to determine if ECoG brain signals can be used to produce speech.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21
- •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.
- •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.
- •If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
- •Must live within a two-hour drive of UCSF
排除标准
- •Pregnancy or breastfeeding
- •Inability to understand and/or read English
- •Inability to give consent
- •Dementia, based on history, physical exam, and MMSE
- •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.)
- •History of suicide attempt or suicidal ideation
- •History of substance abuse
- •Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure
- •Inability to comply with study follow-up visits
- •Any prior intracranial surgery
- •History of seizures
- •Immunocompromised
- •Has an active infection
- •Has a CSF drainage system or an active CSF leak
- •Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition
- •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
- •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)
研究组 & 干预措施
Electrocorticography-based brain computer interface
干预措施: PMT/Blackrock Combination Device (Device)
结局指标
主要结局
NIDCD Primary Objective 1
时间窗: Up to 6 years post-implant period
To enable communication via text decoded from neural signals.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 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
NIDCD Primary Objective 2
时间窗: Up to 6 years post-implant period
To enable communication via synthesized speech decoded from neural signals.
次要结局
- NIDCD Secondary Objective 1(Up to 6 years post-implant period)
- NIDCD Secondary Objective 2(Up to 6 years post-implant period)
研究者
Karunesh Ganguly
Associate Professor
University of California, San Francisco