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

University of Basel

Status: Enrolling

Conditions: Minimally Conscious State

Treatments: Procedure: Animal Assisted Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06931665

2024-02318

PCEFP1_194591 / 1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

AAT-TAU-AAT-TAU (arm 1)

Experimental group

Description:

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.

Treatment:

Procedure: Animal Assisted Occupational Therapy

TAU-AAT-TAU-AAT (arm 2)

Experimental group

Description:

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.

Treatment:

Procedure: Animal Assisted Occupational Therapy