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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Basel

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Animal Assisted Occupational Therapy

    Procedure/Surgery

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

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: AAT-TAU-AAT-TAU (arm 1)Experimental treatment 1 intervention
Group B: TAU-AAT-TAU-AAT (arm 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Before, during and after AAT and TAU. Approximately three weeks.
2

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

Time frame
Before, during and after AAT and TAU. Approximately three weeks.
3

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

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

Secondary outcomes

1

Other physiological measures 1

• Heart rate (HR) in bpm

Time frame
Before, during and after AAT and TAU. Approximately three weeks.
2

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

Time frame
Before, during and after AAT and TAU. Approximately three weeks.
3

Other physiological measures 3

• Electrodermal activity (EDA) in uS

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

Other outcomes

1

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

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

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

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

Sponsors and contacts

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University of Basel

Lead sponsor

Rehab Basel

Collaborator