Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- EEG signal complexity 1
研究概览
简要总结
This study aims to explore the impact of Animal Assisted Therapy (AAT) on brain signal complexity in patients with minimally conscious state (MCS) by analyzing electroencephalogram (EEG) entropy. MCS patients typically exhibit reduced brain entropy compared to healthy individuals, indicating lower brain complexity. The study will assess whether AAT can enhance this complexity, which is crucial for understanding consciousness levels. Entropy, a measure of randomness in brain activity, will be used to evaluate AAT's effectiveness. In addition, electrocardiography (ECG), electrodermal activity (EDA) and behavioral measurements will also be collected.
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
- None
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
- •Inpatients in one of the study sites
- •Acquired brain injury resulting from either traumatic or non-traumatic events
- •Diagnosis of MCS defined by CRS-R according to the Aspen criteria (Giacino, 2005)
- •Informed consent as documented by signature by the patient's legal representative
- •Physiologically stable
- •Aged 18 or over
排除标准
- •Phobia or allergies to any of the involved animals
- •Medical contraindications: acute or chronic disease (e.g. chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
- •Radical changes in medication (decision made with responsible physician)
结局指标
主要结局
EEG signal complexity 1
时间窗: Before, during and after AAT and TAU. Approximately three weeks.
The EEG signal complexity is measured via entropy computed based on EEG recordings: • Sample Entropy (SampEn): score usually between 0 and 1 with higher score indicating higher entropy
EEG signal complexity 2
时间窗: Before, during and after AAT and TAU. Approximately three weeks.
The EEG signal complexity is measured via entropy computed based on EEG recordings: • Lempel-Ziv complexity (LCZ): score usually between 0 and 1 with higher score indicating higher entropy
EEG signal complexity 3
时间窗: Before, during and after AAT and TAU. Approximately three weeks.
The EEG signal complexity is measured via three measures of entropy computed based on EEG recordings: • Symbolic Transfer Entropy (STE): score usually between 0 and 1 with higher score indicating higher entropy
次要结局
- Other physiological measures 1(Before, during and after AAT and TAU. Approximately three weeks.)
- Other physiological measures 3(Before, during and after AAT and TAU. Approximately three weeks.)
- Other physiological measures 2(Before, during and after AAT and TAU. Approximately three weeks.)
研究者
Fabio Carbone
Doctoral Assistant
University of Basel