Cortical Excitability in Patients With Severe Brain Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Short Afferent Inhibition
研究概览
简要总结
The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that:
- There is a continuous decrease in intracortical inhibition from healthy subjects to awake patients with severe brain injury, and to patients with impaired consciousness.
- Decreased intracortical inhibition correlate with the degree of impairment assessed with the clinical scores in patients with severe brain injury.
详细描述
Design: Prospective controlled non-randomized study. Materials and methods: 30 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
- Clinical assessment (Rancho Los Amigos Scale, Functional Independence Measure, Early Functional Abilities).
- Somatosensory Evoked Potentials.
- Transcranial Magnetic Stimulation: single and paired stimulation protocols.
Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (awake patients vs patients with disorders of consciousness vs control persons) and intra-individually factors as 1) interstimulus intervals for transcranial magnetic stimulation and clinical scores (RLAS vs FIM vs EFA).
Significance level is set to 0.05 for all effect parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •severe brain injury (Glasgow Coma Scale score (GCS) less than 8 on admission to the acute hospital);
- •stable vital functions;
- •age over 18 years old;
- •informed content from patient/relatives/legal guardian.
排除标准
- •other neurological diseases than brain injury;
- •TMS contraindications (epilepsy, metallic implantants: pacemaker or medicine pump, ferromagnetic or electronically operated stapedial implants, haemostatic clips, metallic splinters in the orbit).
结局指标
主要结局
Short Afferent Inhibition
时间窗: Within one week after clinical assessment
次要结局
- Short Intracortical Inhibition(Within one week after clinical assessment)
- Intracortical Facilitation(Within one week after clinical assessment)
- Motor threshold(Within one week after clinical assessment)