Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity
研究概览
简要总结
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.
This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.
详细描述
This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities)
- •Patients with stable clinical examination
- •Age between 18 and 80 years
- •Brain injury confirmed by cerebral imaging (MRI or TDM)
- •Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)
排除标准
- •Status epilepticus
- •Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
- •Pregnancy
- •Patients underage
结局指标
主要结局
Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity
时间窗: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at baselne (Day1)
Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA)
时间窗: Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th)
Comparison of the CRS-R score at the tenth day of 0.2mA stimulation (Day14 or Day28) with the score at the tenth day of 2mA stimulation (Day14 or Day28)
Change from baseline of the Coma Recovery Scale-Revised score after 2mA tDCS current intensity
时间窗: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Comparison of the CRS-R score at the tenth day of 2mA stimulation (Day14 or Day28) with the score at baselne (Day1)
次要结局
- IChange of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity(Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th))
- Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 0.2mA tDCS current intensity(Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st))
- Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity(Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st))
- Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 2mA tDCS current intensity(Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st))
- IChange of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity(Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th))
- Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 0.2mA tDCS current intensity(Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st))
研究者
LIONEL NACCACHE
MD, PhD
Groupe Hospitalier Pitie-Salpetriere