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

NCT06931665 | Recruiting DMC

• 2 other identifiers: 2024-02318PCEFP1_194591 / 1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Minimally Conscious State

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Other physiological measures 1

  Before, during and after AAT and TAU. Approximately three weeks.

• Other physiological measures 2

  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 Outcomes (2)

• Behavioral data assessing state of consciousness 1

  From enrollment to the end of treatment at 2 weeks. Day 1 and last day

• Behavioral data assessing state of consciousness 2

  From enrollment to the end of treatment at 2 weeks. Two pre-session measures per week, two post-session measures per week

Study Arms (2)

AAT-TAU-AAT-TAU (arm 1)

EXPERIMENTAL

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

TAU-AAT-TAU-AAT (arm 2)

EXPERIMENTAL

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

Interventions

Animal Assisted Occupational Therapy PROCEDURE

AAT is an ergotherapy including an animal. AAT is a specific type of Animal Assisted Intervention (AAI) with a therapeutic aim.

Also known as: Animal Assisted Therapy, AAT, ergotherapy

AAT-TAU-AAT-TAU (arm 1); TAU-AAT-TAU-AAT (arm 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Basel: lead
• Rehab Basel: collaborator

Study Sites (2)

REHAB Basel

Basel, Switzerland

RECRUITING

Service de Neurorééducation, Hopitaux Universitaires Genevois

Geneva, Switzerland

RECRUITING

MeSH Terms

Conditions

Persistent Vegetative State

Interventions

Animal Assisted Therapy; Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Fabio Carbone, MSc

CONTACT

+41612076738; fabio.carbone@unibas.ch

Karin Hediger, Prof

CONTACT

karin.hediger@unilu.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Assistant

Model Details: Randomized, controlled cross-over within-subject trial with two arms

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 17, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)