Effect of Individual Biofeedback Transcranial Magnetic Stimulation Assessed by a Hybrid Neural Network Evaluation Model on Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Coma Recovery Scale Revised (CRS-R)
研究概览
简要总结
This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC.
详细描述
Despite continued advances in life-sustaining intensive care for severe brain injury patients, little can be done to promote behavioral recovery in patients with disorder of consciousness (DoC). Arousal is the primary task in the rehabilitation of patients with impaired consciousness. Evidence suggests that some medications and physical therapies can induce wakefulness by reactivating specific pathways that lead to impaired consciousness. However, due to the complexity of the type, degree, location, and other related influencing factors of brain injury, the current commonly used treatment options are not effective for patients with impaired consciousness, and the theoretical basis for benefit is not sufficient.
This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC.
Before and after a course of treatment (20 days), activation and connectivity of patients' arousal centers will be assessed through a hybrid neural network evaluation model, which consists of comprehensive cortical connectivity parameters (perturbational complexity index and evoked high-frequency oscillations) and region-specific cortical connectivity parameters (short-latency afferent inhibition and mismatch negativity). Each parameter is clinically used to assess a patient's level of cortex connectivity. This hybrid evaluation model may give a comprehensive evaluation of a patient's degree of awareness, and enhance our understanding of the mechanisms underlying these conditions.
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
- Single (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
- •7-28 days after ischemic stroke
- •behavioral profile consistent with a UWS or MCS as assessed with the Coma Recovery Scale Revise
- •prestroke Modified Ranking Scale(mRS) ≤2
排除标准
- •history of vascular malformation or aneurysmal SAH or untreated aneurysm prior to stroke
- •disorder of consciousness prior to stroke
- •impairment of hearing
- •metal implants, e.g. stenting, pacemaker, etc.
- •contraindications to MRI, such as claustrophobia
- •history of epilepsy or epileptic episodes
- •suffering from serious diseases such as malignant tumors, etc., with expected survival time <1 year
- •patient is currently involved with other trials
结局指标
主要结局
Coma Recovery Scale Revised (CRS-R)
时间窗: Change in maximum CRS-R score from baseline to 1 month
The Coma Recovery Scale Revised (CRS-R) is a standard clinical protocol specifically developed to assess a patient's level of consciousness, and does so by evaluating a patient's level of responsiveness to sensory stimulation, their ability to understand language, and to communicate. This procedure is typically administered at bedside. The protocol is divided into 6 sub-scales, each assessing a different area (e.g., visual function, auditory function, communication, arousal), and the final score is calculating by adding all sub-scales.The total score of this scale goes from its minimum, 0, which implied a state of coma, to 23, which implies emergence from a Minimally Conscious State (i.e., eMCS). Higher values thus map onto better outcomes.
Number of Participants With (Severe) Adverse Events
时间窗: day 20 (+/-3)
Number of AEs and SAEs occurring throughout the paradigm.
次要结局
- Number of voxels in which the Functional Magnetic Resonance Imaging (fMRI) signal is significantly associated to TMS across the whole group(Change from baseline to 1 month)
- Hybrid Neural Network Evaluation(Change from baseline to day 20 (+/-3))
研究者
Liping Liu
Professor
Beijing Tiantan Hospital
