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: 2024年7月8日

适应症

试验速览

暂无简介。

•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

•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

发起方

Amsterdam UMC