NL-OMON54701招募中不适用
REstoring CONsciousness with NEurostimulation of the Central Thalamus in patients with a persistent minimally conscious state (RECONNECT): a pilot study - RECONNECT
Amsterdam UMC0 个研究点目标入组 6 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
- 招募中
- 发起方
- 入组人数
- 6
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 64（—）
入选标准
- •Age 18-65 years
- •Diagnosis of MCS according to CRS-R
- •The patient is in persistent MCS, i.e. at least 24 months post-injury
- •MCS is caused by non-progressive traumatic brain injury (TBI)
- •MCS is treatment-refractory, defined as:
- •- not accompanied by concomitant hydrocephalus
- •- accompanied by concomitant hydrocephalus that has been adequately treated by
- •permanent cerebrospinal fluid shunting for at least six months with no evidence
- •of improvement in neurobehavioral function in the last two months prior to
- •- previous failure of emergence from MCS by treatment with amantadine, levodopa
- •and zolpidem
- •Independent ventilation
- •Stable physical condition
- •Written informed consent by primary family caregivers
排除标准
- •Expectation that patients will not be able to meaningfully interact with the
- •outside world even when consciousness is restored, defined as:
- •- evidence of significant lesions involving cortical language areas (Wernicke's
- •and/or Broca's - area) or brainstem on MRI
- •- quadriplegia due to spinal cord injury, brainstem injury, or bilateral loss
- •of motor cortex on MRI
- •Premorbid mental retardation
- •MRI-incompatible cardiac pacemaker/defibrillator
- •Intractable seizure disorders (status epilepticus)
- •Presence of untreated endocrine disturbances (i.e., hyper- or hypothyroidism)
- •or other biochemical disturbances
- •Medical contraindications for DBS or general anesthesia, and comorbid
- •conditions, including:
- •- non-closed skull due to previous decompressive hemicraniectomy without proper
- •cranioplasty
- •- anatomical barriers for electrode placement on MRI
- •- local, systemic, acute, or chronic infectious illness
- •- severe collagen vascular disorder/bleeding disorders
- •- severe chronic pulmonary disease
- •- life-threatening cardiac arrhythmias
- •- kidney failure or other major organ systems failures
- •- other active neurologic diseases/processes (i.e., multiple sclerosis,
- •Parkinson*s disease, Alzheimer*s disease)
- •- neoplasm with life expectancy <5 years
研究者
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