Sub-study of the NEURODOC Project (Electrophysiological Evaluation of Consciousness in Patients With Disorders of Consciousness During Standard Care Procedures): Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Support vector machine multivariate prediction of consciousness from resting state EEG markers
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 mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients.
In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.
详细描述
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 (1, 2, 3, 4), with no side effects reported.
However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of the stimulation have never been studied in disorders of consciousness patients.
In this study, the investigators will use detailed clinical examinations (Coma Recovery Scale - Revised (5)) and electrophysiological assessments (quantitative high-density EEG and event-related potentials) (6, 7) and event-related potentials (8, 9) together with a standard morphological MRI to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.
The primary goal is to investigate electrophysiological response to tDCS and its relation to behavioral response to better understand how tDCS affects consciousness in disorders of consciousness patients.
References:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Age between 18 and 80 years
- •Disorder of consciousness assessed by CRS-R (VS, MCS, exitMCS)
- •Patients with stable clinical examination (even in intensive care unit)
- •Structural brain injury confirmed by cerebral imaging (MRI or TDM)
排除标准
- •Refractory status epilepticus
- •Known preexisting severe neurodegenerative disease (ie: Alzheimer disease, Lewy body dementia, ...)
- •MRI contraindication: metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis
- •Pregnant, parturient or breastfeeding women
研究组 & 干预措施
Clinical and electrophysiological evaluation of tDCS session
In this prospective case-control study, the investigator's main goal was to evaluate the impact of a single standard-care tDCS session on brain activity (EEG).
The effect of a single 20 minutes 2 mA tDCS session with the anode placed over the left dorsolateral prefrontal cortex and the cathode over the right supraorbital cortex administered as routine care were evaluated by combined behavioral and electrophysiological assessments immediately before and after the stimulation.
The study consisted of the following interventions, administered immediately before and after the stimulation session:
- detailed behavioral assessment by the Coma Recovery Scale-Revised (CRS-R)
- 5 minutes resting state high-density EEG recordings and 6 minutes auditory oddball paradigm immediately.
Additionally, clinical anatomical MRI (T1) acquired as routine care were used to model the estimated tDCS-induced electric fields in the entire head of patients, based on available T1-weighted MRI.
干预措施: Coma Recovery Scale - revised (Behavioral)
Clinical and electrophysiological evaluation of tDCS session
In this prospective case-control study, the investigator's main goal was to evaluate the impact of a single standard-care tDCS session on brain activity (EEG).
The effect of a single 20 minutes 2 mA tDCS session with the anode placed over the left dorsolateral prefrontal cortex and the cathode over the right supraorbital cortex administered as routine care were evaluated by combined behavioral and electrophysiological assessments immediately before and after the stimulation.
The study consisted of the following interventions, administered immediately before and after the stimulation session:
- detailed behavioral assessment by the Coma Recovery Scale-Revised (CRS-R)
- 5 minutes resting state high-density EEG recordings and 6 minutes auditory oddball paradigm immediately.
Additionally, clinical anatomical MRI (T1) acquired as routine care were used to model the estimated tDCS-induced electric fields in the entire head of patients, based on available T1-weighted MRI.
干预措施: Electrophysiological recordings (Diagnostic Test)
结局指标
主要结局
Support vector machine multivariate prediction of consciousness from resting state EEG markers
时间窗: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Change from baseline of the predicted probability of conscious state, ie. to be classified a in a 'minimally conscious state' as opposed to be classified as in a 'vegetative state'. The prediction will be based on a set of markers extracted from the EEG (power spectra, information theory, complexity and connectivity markers) and will use a support vector machine classifier algorithm train on a validated database. See Sitt et al., Brain et al. 2014. for details on the EEG preprocessing, markers extraction, support vector machine algorithm and training database.
Evoked response potential during auditory oddball paradigm
时间窗: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Change of the Evoked Response Potentials recorded during the auditory oddball paradigm
次要结局
- Resting state EEG individual markers(Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation))
- State of consciousness(Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation))
研究者
LIONEL NACCACHE
Professor
Groupe Hospitalier Pitie-Salpetriere