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

Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study

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.

Study Overview

• Status: Recruiting
• Conditions: Minimally Conscious State
• Intervention / Treatment: Procedure: Animal Assisted Occupational Therapy

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Carbone, MSc; Phone Number: +41612076738; Email: fabio.carbone@unibas.ch
• Study Contact Backup: Name: Karin Hediger, Prof; Email: karin.hediger@unilu.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • REHAB Basel
    • Contact: Fabio Carbone; Phone Number: +41 61 207 67 38; Email: fabio.carbone@unibas.ch
  • Geneva, Switzerland
    • Recruiting
    • Service de Neurorééducation, Hopitaux Universitaires Genevois
    • Contact: Fabio Carbone; Phone Number: +41 61 207 67 38; Email: fabio.carbone@unibas.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AAT-TAU-AAT-TAU (arm 1); Each patient will undergo two therapy sessions per week, with a total of four sessions integrated into their clinical routine. In this arm, patients will start with the AAT intervention, followed by a TAU intervention in the same week. In week two, the patient will again receive an AAT intervention followed by the last TAU intervention.	Procedure: Animal Assisted Occupational Therapy; AAT is an ergotherapy including an animal. AAT is a specific type of Animal Assisted Intervention (AAI) with a therapeutic aim.; Other Names: AAT; Animal Assisted Therapy; ergotherapy
Experimental: TAU-AAT-TAU-AAT (arm 2); Each patient will undergo two therapy sessions per week, with a total of four sessions integrated into their clinical routine. In this arm, patients will start with the TAU intervention, followed by an AAT intervention in the same week. In week two, the patient will again receive a TAU intervention followed by the last AAT intervention.	Procedure: Animal Assisted Occupational Therapy; AAT is an ergotherapy including an animal. AAT is a specific type of Animal Assisted Intervention (AAI) with a therapeutic aim.; Other Names: AAT; Animal Assisted Therapy; ergotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before, during and after AAT and TAU. Approximately three weeks.
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	Before, during and after AAT and TAU. Approximately three weeks.
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	Before, during and after AAT and TAU. Approximately three weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other physiological measures 1	• Heart rate (HR) in bpm	Before, during and after AAT and TAU. Approximately three weeks.
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	Before, during and after AAT and TAU. Approximately three weeks.
Other physiological measures 3	• Electrodermal activity (EDA) in uS	Before, during and after AAT and TAU. Approximately three weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of treatment at 2 weeks. Day 1 and last day
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	From enrollment to the end of treatment at 2 weeks. Two pre-session measures per week, two post-session measures per week

Collaborators and Investigators

• Sponsor: University of Basel
• Collaborators: Rehab Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Brain Damage, Chronic; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Persistent Vegetative State; Therapeutics; Physical Therapy Modalities; Patient Care; Health Services; Health Care Facilities Workforce and Services; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Occupational Therapy; Animal Assisted Therapy
• Other Study ID Numbers: 2024-02318; PCEFP1_194591 / 1 (Other Grant/Funding Number: Swiss National Science Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No