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NCT Number: NCT06931665

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

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.

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Key information

Conditions

Minimally Conscious State Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHAB Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Animal Assisted Therapy, AAT, ergotherapy

Primary outcomes

  1. EEG signal complexity 1

    Time frame: 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

  2. EEG signal complexity 2

    Time frame: 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

  3. EEG signal complexity 3

    Time frame: 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 outcomes

  1. Other physiological measures 1

    Time frame: Before, during and after AAT and TAU. Approximately three weeks.

    • Heart rate (HR) in bpm

  2. Other physiological measures 2

    Time frame: 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

  3. Other physiological measures 3

    Time frame: Before, during and after AAT and TAU. Approximately three weeks.

    • Electrodermal activity (EDA) in uS

Other outcomes

  1. Behavioral data assessing state of consciousness 1

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

    • Coma Recovery Scale - Revised (CRS-R): score from 0 to 23 with higher score indicating higher consciousness level

  2. Behavioral data assessing state of consciousness 2

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

    • Basler Vegetative State Assessment (BAVESTA): 22 items with a score from 0 to 5 with higher total score indicating higher level of consciousness

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Carbone, MSc

CONTACT

[email protected]

+41612076738

Karin Hediger, Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Collaborators

  • Rehab Basel

Registry information

Official study title

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

Acronym: EMCS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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