Effect of Transcranial Electrical Stimulation on the Consciousness of Non-communicating Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- State of consciousness
研究概览
简要总结
The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious state of non-communicating patients. tACS and tDCS are non-invasive stimulation techniques that are used to induce brain oscillations at certain frequency or to increase the brain activity in applied region.
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 and transcranial Alternative Current Stimulation (tACS), with the ability to stimulate cortex at specific frequencies and to manipulate phase-synchrony between regions is a promising techniques to improve patients' consciousness.
In this study, the investigators will use prefrontal tDCS and theta tACS to improve patients consciousness level.
详细描述
This study is constituted of two independent sub-studies investigating two types of stimulation (tDCS and tACS) with the same cross-over design
Study design The study design is composed of two experimental sessions, one active stimulation and one sham comparator. Sessions will be randomized in a double-blind randomized crossover design (neither the participant nor the experimenter knows which session includes which stimulation type), with at least 2 days of interval between them.
In these sessions, the patients' state of consciousness participants will first be determined using the dedicated Coma Recovery Scale - Revised (Giacino, Neurology 2002) (CRS-R) scale before stimulation. Resting state brain activity EEG and cognitive auditory paradigm (local-global paradigm, Bekinschtein, PNAS 2009) will also be recorded before stimulation.
Twenty minutes stimulation will then be performed (see below). CRS-R, resting state EEG and local-global paradigm will be repeated after stimulation.
Outcome measures will be the same in the two studies. The primary outcome will be the change of CRS-R between before and after stimulation. Secondary outcomes will be the neurophysiological correlates of consciousness in resting state EEG and during the local global paradigm.
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)
盲法说明
Study will be double-blind : neither participant nor the investigator will know which stimulation type (in-phase active, anti-phase active or sham) is on.
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
- •Non communicative patients with disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)
- •Patients with stable clinical examination (even in intensive care)
- •Brain injury confirmed by cerebral imaging (MRI or TDM)
- •French social security affiliation
- •Signed and informed consent by the patient or by a legal representant
排除标准
- •Status epilepticus or uncontrolled epilepsy
- •Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
- •Electrical stimulation contraindication (metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis)
- •Pregnant, parturient or breastfeeding women- Patients underage
研究组 & 干预措施
In-phase 6 Hz prefronto-parietal tACS
6 Hz stimulation (1000 μA) with transcranial Alternative Current Stimulation (tACS) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3 of the 10-20 international scalp EEG system, with a return electrode in Cz) for 20 minutes. The phase difference between the two stimulation sites will be 0°.
干预措施: In-phase 6 Hz prefronto-parietal tACS (Device)
Sham prefronto-parietal tACS
The same stimulation as in in-phase transcranial Alternative Current Stimulation tACS (6 Hz F3 and P3 stimulation with 0° phase difference) will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. The whole session duration is 20 minutes.
干预措施: Sham prefronto-parietal tACS (Device)
2 mA left prefrontal tDCS
2000 μA anodal transcranial Direct Current Stimulation (tDCS) will be applied over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system with a right supraorbital return electrode (Fp2 of the 10-20 international scalp EEG system) during 20 minutes.
干预措施: 2 mA left prefrontal tDCS (Device)
Sham left prefrontal tDCS
The same stimulation as active transcranial Direct Current Stimulation (tDCS) (anodal F3 and return in Fp2) will start at 2 mA intensity for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. The whole session duration is 20 minutes.
干预措施: Sham left prefrontal tDCS (Device)
结局指标
主要结局
State of consciousness
时间窗: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Change of the Coma Recovery Scale-Revised scores (CRS-R, Giacino et al. Neurology 2002 and Kalmar et al., Neuropsychol Rehabil 2005) between before and after stimulation (CRS-R post stimulation - CRS-R before stimulation). The CRS-R score is a qualitative and quantitative scales ranking predefined behaviors elicited by the patients in the following six subscales, auditory function, visual function, motor function, verbal and oromotor function, communication and wakefulness, the sum of which give a total score ranging from 0 to 23. Higher values of the scale mean a better state of consciousness. This change in state of consciousness will be compared between active stimulation and sham stimulation
次要结局
- Evoked response potential during local-global paradigm(Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation))
- Resting state EEG(Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation))