Sham-controlled, Double-blind, Randomised Crossover Study of the Neural, Behavioural, and Clinical Effects of Transcranial Direct Current Stimulation in Patients With a Prolonged Disorder of Consciousness; Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Retention at 6 months
研究概览
简要总结
This study evaluates the feasibility of an experimental protocol that combines advanced multi-modal imaging of the brain with clinical and behavioural scales to characterise the neural, behavioural, and clinical effects of transcranial direct current stimulation (tDCS) for rehabilitation in PDOC
详细描述
Patients with prolonged disorders of consciousness (PDOC) have very limited therapeutic options, and they often show little to no progress over time. Here, the investigators will assess whether transcranial direct current stimulation can improve patients' responsiveness. The investigators will use a protocol designed to target specific brain networks that have been shown to play a key role in explaining the lack of voluntary responses in PDOC. The study will focus on characterising the mechanisms of action of tDCS and the bases for potential individual differences in responsiveness to the stimulation across participants. This feasibility study is the first step towards developing personalised tDCS interventions to restore external responsiveness in PDOC patients. Its results will inform the design of a future trial fully powered for characterising neural, behavioural, and clinical effects of tDCS in PDOC as well as the mechanisms underlying individual differences in responsiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the MRI stream all participants will receive anodal, cathodal, and sham (placebo) tDCS sessions in a randomised order. In the Bedside stream participants will receive active tDCS (either anodal or cathodal) and sham sessions also in a randomised order. A researcher not involved in data collection or analyses will programme the stimulator to deliver the specific polarity needed in each session in a double-blind manner. Sham tDCS will be delivered according to published guidelines: this mimics the physical sensations of active stimulation but does not have a neuromodulatory effect
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
- •Aged 18 years or older
- •Receiving care at a recruitment site, with a consensus clinical diagnosis of PDOC from any aetiology (i.e. traumatic or non-traumatic injury).
- •Stable and with no need of mechanical support (i.e. respirator, etc.)
排除标准
- •Scalp skin sores or any skin damage at the electrode sites
- •Metallic implants in the face or skull
- •Craniectomy or cranioplasty
- •No evidence of auditory startle in clinical observations, or absent brainstem auditory evoked potentials in recent clinical history (if data available)
- •MRI incompatible: metal plates incompatible with MRI scanners, pacemaker, inability to lay flat for prolonged periods of time, aneurysm clips, neurostimulators, brain/subdural electrodes, etc. (MRI stream ONLY)
结局指标
主要结局
Retention at 6 months
时间窗: 6 months after start of participation
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure). This Outcome applies to the bedside stream only
Completion
时间窗: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
percentage of tDCS, MRI, and electrophysiology assessments completed per polarity
Retention at end of active phase
时间窗: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure)
Retention at 3 months
时间窗: 3 months after start of participation
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure). This Outcome applies to the bedside stream only
次要结局
- Functional MRI in response to task instructions(day 1 and day 5 of tDCS each polarity)
- EEG power in the beta band in response to task instructions(days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream)
- EMG (electromyography) amplitude changes(days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively)
- Structural MRI(day 1 and day 5 of tDCS each polarity)
- EEG power in the alpha band in response to task instructions(days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream)
- Coma recovery scale -revised(regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream)
- Glasgow Outcome Scale-extended(at 3 and 6 months after start of participation)