Transcranial Direct Current Stimulation (tDCS) Effects in Patients With Chronic Consciousness Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Coma Recovery Scale Revised (CRS-R)
研究概览
简要总结
Chronic consciousness disorders have high level of impact on public health and its costs.
详细描述
Consciousness disorders have high impact on society and national health system. One of these disorders is vegetative condition in which, as in coma, there isn't any self or environmental consciousness but there is alertness, whereas in minimal state of consciousness at least part of awareness is conserved.
In Emilia Romagna region about 80 people per million of inhabitants are hospitalized after cerebral damage, and after discharge about 1/5 of patients are stabilized in a consciousness disorder.
The diagnosis of these disorders is based on neurobehavioural tests, for example JFK Coma Recovery Scale Revised (CRS-R).
In these patients recovery of state of consciousness is one of the main challenges. There are very little evidences about treatment, it has been proposed the use of therapies that could modulate central nervous system activity, like specific drugs, neuroimaging and neuromodulation techniques such as transcranial magnetic stimulation and repetitive transcranial current stimulation.
A non invasive neuromodulation technique is transcranial direct current stimulation (tDCS) which can modulate cortical excitability: cathodic current reduces excitability whereas anodic current increases it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females aged >18 years old and <70 years old
- •diagnosis of disorders of consciousness classified as MCS according to criteria of American Academy of Neurology
- •traumatic etiology (>12 months after the acute injury)
排除标准
- •contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants, history of seizures, metal in the head, implanted brain medical devices.
- •contraindications to tDCS such as metal in the head, implanted brain medical devices.
结局指标
主要结局
Coma Recovery Scale Revised (CRS-R)
时间窗: Change measures (weeks: -2,0,1,2,4)
behavioural scale (visual, auditory, motor, verbal, communication, arousal)
次要结局
- single-pulse transcranial magnetic stimulation (TMS)(Change measures (weeks: -2,0,1,2,4))
- Circulating Biomarkers(Change measures (weeks: -2,0,1,2,4))
- electroencephalography (EEG)(Change measures (weeks: -2,0,1,2,4))
- functional near infrared spectroscopy (fNIRS)(Change measures (weeks: -2,0,1,2,4))
研究者
Sofia Straudi, MD
MD
University Hospital of Ferrara