Double-blind Randomized Controlled Trial of a 10-Hz Transcranial Alternating Current Stimulation to Modulate Brain Activity in Brain-injured Patients With Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 主要终点
- Change in Functional Connectivity based on EEG signal
研究概览
简要总结
This study first aims to validate the feasibility of a multimodal 5-day 20-minute tACS protocol in subacute brain-injured patients with a disorder of consciousness during their ICU stay, and conduct a clinical pilot study (validation phase). Upon completion of this validation phase and according to obtained results, a randomized clinical trial will be conducted to compare the effects of the 5-day active 10Hz-tACS protocol with a 5-day sham-tACS protocol on brain dynamics modulation. This study will also compare intervention conditions on recovery of consciousness, cognition and function using short-term and long-term measurements.
详细描述
Background: After a severe brain injury, a significant number of patients remain in a state of altered consciousness and the outcome remains difficult to prognosticate. There is a lack of evidence-based therapeutic interventions available for patients with disorders of consciousness; some evidence has been gathered for non-invasive brain stimulation, but these have targeted chronic patients. The objective of the validation phase will be to evaluate the differential feasibility parameters of conducting a 5-day tACS stimulation protocol in the ICU and the quality of data collection according to the various measurement modalities, to establish requirements to be used in a larger-scale study. This phase will also implicate a clinical pilot to confirm and assess the effect size of the primary outcome and sample size requirements for a clinical trial. Following completion, a clinical trial will be conducted to evaluate short-term and long-term neurophysiological effects of an optimized, multi-session tACS intervention in subacute brain-injured patients on their consciousness and functional recovery (as measured by complementary behavioural/functional scales), related brain oscillations and network dynamics.
Validation phase: In addition to conducting the following methods and design protocol, these measures will be acquired during the validation phase to assess the feasibility of this single-site study.
Recruitment rate and retention: Estimated number of patients in this condition in this ICU per year, estimated patient survival rates, number of eligible patients over a 12-month recruitment period; percentage of patients recruited, attrition, presence of competitive studies, etiologies and compliance of the families through experimental protocol and longitudinal assessment (12-month period).
Site demographics: Personnel's availabilities, Availability/accessibility of study coordinators, technicians, doctors and nurses; competency of the experimental team to conduct the experimental protocol.
Site infrastructure: Material storage (biological samples (centrifuge, freezer), Material obtention (Lidocaine obtention and renewal; EEG equipment), Data storage (clinically secure on-site servers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years old; Glasgow Coma Scale score remaining ≤ 12 following a minimum of 24 hours after the withdrawal of continuous sedation (if applicable).
- •The included brain injury etiologies for the Unresponsive Wakefulness Syndrome(UWS) or Minimally Conscious State (MCS) are traumatic and non-traumatic (e.g., traumatic brain injury, anoxic brain injury, subarachnoid hemorrhage).
排除标准
- •Focal brain lesion(s) in the occipital and parietal lobes located at stimulation site
- •Pre-existing severe neurological conditions/disorders involving cognitive deficits such as neurodegenerative diseases (ALS, dementia, Parkinson's), hereditary conditions (e.g. Huntington's Chorea), CNS disorders (previous moderate-severe CBT)
- •History of epilepsy (patient with a seizure episode in response to non-exclusive active tACS intervention)
- •Aneurysm clip(s), subdural brain electrodes, metallic brain, an implant, implantable neurostimulator
- •Craniectomy with no bone flap
- •Cervical collar limiting access to the occipital region
- •Participation in a current (or previous) study that may have a confounding effect, as assessed by the research team.
- •To facilitate recruitment, upon medical consent family members of patients who present inclusion criteria before meeting the protocol activation criteria will be approached by the research team to get informed consent. The study will be activated once the medical team confirms clinical stability and withdrawal of continuous sedation for a minimum of 24 hours. The study protocol will not be activated if there is: Constant and intense agitation at the time of study activation, the presence of invasive neurological monitoring (ICP and/or PbtO2), GCS > 12 after 24 hours of continuous sedation.
研究组 & 干预措施
10-Hz tACS Stimulation Group
tACS stimulation will be delivered over to parieto-occipital sites using only 2-minute ramp up and down and a continuous 20-minute 10 Hz sinusoidal current administered. The stimulation electrode montage will be identical for both conditions.
干预措施: Active Transcranial alternative current stimulation (Device)
Sham Stimulation Group
Sham stimulation will be delivered over to parieto-occipital sites using only 2-minute ramp up and down, without any sinusoidal current administered for 20 minutes. The stimulation electrode montage will be identical for both conditions.
干预措施: SHAM Transcranial alternative current stimulation (Device)
结局指标
主要结局
Change in Functional Connectivity based on EEG signal
时间窗: It will be measured over the 2-week course of the experimental protocol
Examine changes in the statistical relationship between specific electrophysiological signal parameters in time.
Single-site recruitment rates
时间窗: 1 year
Quantify the frequency of recruitment in the entire study's protocol for the specific population in the Intensive Care Unit.
Retention rates
时间窗: over the 2-week course of the experimental protocol and at 3, 6 and 12 month time points
Assess completion and participation in the entire study's from participants and their caregivers; for the intervention protocol as well as for longitudinal measures over time \[3,6,12 months\]
Change in EEG spectral power of the alpha band activity
时间窗: It will be measured over the 2-week course of the experimental protocol
EEG measures cortical electrical activity. Increase in the alpha band spectral power after the end of the 5-day 20-minute 10 Hz tACS intervention would indicate the specificity of the modulation's effect.
次要结局
- Changes in Coma Recovery Scale Revised (CRS-R) score throughout the protocol.(It will be measured over the 2-week course of the experimental protocol)
研究者
Louis De Beaumont
Principal Investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal