NL-OMON53918尚未招募不适用
Investigation on the Cortical Communication (CortiCom) System - CortiCom
niversitair Medisch Centrum Utrecht0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •18-70 years
- •Clinical diagnosis of locked-in state caused by traumatic brain injury,
- •brainstem stroke,
- •neurodegenerative disease, neuromuscular disease or another cause
- •Complete or incomplete tetraplegia (quadriplegia) or tetraparesis
- •(quadriparesis)
- •Motor-related speech impairment (dysarthria or anarthria)
- •Either receiving tracheostomy invasive ventilation, or having a stable and
- •respiratory situation without respiratory support, allowing for safe
- •intubation, mechanical ventilation and detubation during surgery according to
- •the involved clinicians, and, if relevant (e.g., in case of a progressive
- •condition), in combination with a confirmed desire to receive tracheostomy
- •invasive ventilation when that becomes necessary
- •Meeting surgical safety criteria, including surgical clearance by the study
- •Meeting (neuro)psychological evaluation criteria
- •Ability to communicate reliably, such as through eye movement
- •Willingness and ability to provide informed consent
- •Lives within reasonable distance from UMC Utrecht
- •Participant consents to the study and still wishes to participate at the time
- •of the study
- •Vision and hearing largely intact
排除标准
- •Performance on formal neuropsychological testing that indicates a significant
- •recent psychiatric disorder, cognitive or behavioral impairment, that would
- •interfere with obtaining informed consent or fully participating in study
- •Medical conditions contraindicating surgery of a chronically implanted device
- •or that could
- •interfere with study participation (for example active infections, unexplained
- •fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any
- •autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin
- •sloughing or poor wound healing, cranioplasty, significant cardiovascular,
- •metabolic, or renal impairments, chronic oral or intravenous use of steroids or
- •immunosuppressive therapy, active cancer within the past year or requires
- •chemotherapy, uncontrolled autonomic dysreflexia within the past 3 months,
- •hydrocephalus with or without an implanted ventricular shunt or a medical
- •contraindication to stop anti-coagulant medications during surgery)
- •Presence of pre-surgical findings in anatomical, functional, and/or vascular
- •neuroimaging that makes achieving implant locations too challenging or
- •incompatible with desired risk levels
- •Inability to undergo MRI for pre-implantation evaluation, for example due to
- •the presence
- •of implanted devices that are incompatible with MRI, which may include
- •pacemakers,
- •cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain
- •stimulators, and
- •cochlear implants
- •Anticipated need for MRI after implantation of the CortiCom assembly
研究者
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