Clinical, Neurophysiological and Genetical Predictors of Consciousness Recovery and Functional Outcomes After Severe Acquired Brain Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Consciousness recovery
研究概览
简要总结
Severe Acquired Brain Injury is defined as a traumatic, post-anoxic, vascular or other brain damage that causes coma for at least 24 hours and leads to permanent disability with sensorial, motor, cognitive or compartmental impairment. In this context, an accurate characterization of individual patients' profile in terms of neuronal damage, potential for neuroplasticity, neurofunctional and clinical state could allow to plan tailored rehabilitation and care pathway on the basis of solid prognostic information, also for optimizing resources of the National Health care systems and enhance ethical decisions. Patient profiling should encompass measures and procedures easily available at the bedside, and with affordable time, resource, and money-costs to determine a real impact on National Health systems. The aim of the study is identifying patient profiles in terms of clinical, neurophysiological and genetical aspects with better long-term outcome in order to plan tailored therapeutic interventions.
详细描述
Background:
After a severe Acquired Brain Injury (sABI) the consciousness, the functional and the cognitive recovery of the patients depends on the severity of the damage suffered but also on the vulnerability of the individual brain. Some patients with sABI may survive in a state of Disorder of Consciousness (DoC) condition (i.e., patients in vegetative state/unresponsive wakefulness syndrome, VS/UWS or in minimally conscious state, MCS). Other patients, despite having a complete recovery of consciousness, can reach very variable degrees of functional and cognitive autonomy. The prognostic factors of consciousness recovery of patients with DoCs have been thoroughly investigated. Most of these studies investigated the acute phase, while only a few studies have examined the role of early clinical factors emerging before the complete recovery of consciousness . Further prognostic insights can be provided by analysis of genes coding for Apolipoprotein E (APOE), dopamineD2 receptor (DRD2), and Brain Derived Neutrophic Factors (BDNF), and by markers of axonal injury.
Study aim:
The present project aims at identifying patient profiles with better long-term outcome in order to plan tailored therapeutic interventions.
The patient profiles will be drawn up by gathering patient's demographic (age, gender, social and educational level), anamnestic (aetiology and time post-brain injury, Cognitive Reserve Index), clinical state (Cumulative Illness Rating Scale (CIRS), CRS-R total score and corresponding consciousness state; Disability Rating Scale, DRS, Functional Oral Intake Scale; FOIS, Glasgow Outcome Scale Expanded; GOS-E, Level of Cognitive Functioning; LCF) and neurophysiological data (Electroencephalogram (EEG), Somatosensory evoked potentials (SEP), and Motor evoked potentials (MEP) nerve conduction aimed at evaluating occurrence of critical illness polyneuropathy and myopathy (CIPNM)) at study entry (baseline), together with neural biomarkers (genetic markers).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted with a history of severe Acquired Brain Injury within 4 months,
- •aged 18+,
- •signed informed consent signature for the participation to the study
- •signed informed consent signature for the participation to for the genetic analysis
排除标准
- •patients admitted with a history of severe Acquired Brain Injury more then 4 months
- •Absence of informed consent to participate in the study
结局指标
主要结局
Consciousness recovery
时间窗: 24 months
The Consciousness recovery will be measured throught the italian version of the CRS-R performed for at least 5 time during one week to avoid a misdiagnosis due to consciousness fluctuations.Consciousness recovery is defined as CRS_R \>23 and Improvement Responsiveness will be registred for patients transitioning from UWS to MCS or E-MCS, and from MCS to E-MCS.
Time to decannulation
时间窗: 24 months
In decannulated patients, time between admission in the IRU and decannulation will be reported
Tracheostomy weaning
时间窗: 24 months
Tracheostomy weaning will be reported as a dichotomic variable: decannulated yes/no
Total oral feeding recovery
时间窗: 24 months
The swallowing severity will be assessed throught the Oral feeding recovery measured by Functional Oral Intake Scale (FOIS) scoring from 1 (severe dysphagia) to 7(absence of dysphagia). The outcome of "oral feeding recovery" corrispond to Functional Oral Intake Scale\>4
Functional autonomy
时间窗: 24 months
Functional autonomy measured by Glasgow Outcome Scale Expanded scoring between 1 (death) and 8 (complete functional recovery). A good autonomy is defined for Glasgow Outcome Scale Expanded \>4
次要结局
- Degree of social and occupational reintegration(24 months)
- Cognitive profile(24 months)
- Subjective and Objective Quality Of Life(24 months)
研究者
Bahia Hakiki
Neurologist, MD, Ph D
Fondazione Don Carlo Gnocchi Onlus