Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State

Not Applicable

Not yet recruiting

• Conditions: Minimally Conscious State

• Registration Number: NCT06931665
• Lead Sponsor: University of Basel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
EEG signal complexity 1	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	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	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

Secondary Outcome Measures

Name	Time	Method
Other physiological measures 1	Before, during and after AAT and TAU. Approximately three weeks.	• Heart rate (HR) in bpm
Other physiological measures 3	Before, during and after AAT and TAU. Approximately three weeks.	• Electrodermal activity (EDA) in uS
Other physiological measures 2	Before, during and after AAT and TAU. Approximately three weeks.	• Heart rate variability (HRV) measured by complexity index (CI): score usually between 0 and 1 with higher score indicating higher complexity