About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Crossover
Treatments tested in this trial
Animal Assisted Occupational Therapy
Procedure/SurgeryAAT is an ergotherapy including an animal. AAT is a specific type of Animal Assisted Intervention (AAI) with a therapeutic aim.
Treatment groups
Trial outcomes
Primary outcomes
EEG signal complexity 1
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
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
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
Secondary outcomes
Other physiological measures 1
• Heart rate (HR) in bpm
Other physiological measures 2
• Heart rate variability (HRV) measured by complexity index (CI): score usually between 0 and 1 with higher score indicating higher complexity
Other physiological measures 3
• Electrodermal activity (EDA) in uS
Other outcomes
Behavioral data assessing state of consciousness 1
• Coma Recovery Scale - Revised (CRS-R): score from 0 to 23 with higher score indicating higher consciousness level
Behavioral data assessing state of consciousness 2
• Basler Vegetative State Assessment (BAVESTA): 22 items with a score from 0 to 5 with higher total score indicating higher level of consciousness
Sponsors and contacts
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University of Basel
Lead sponsor
Rehab Basel
Collaborator