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

NCT ID: NCT06931665

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-08

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Minimally Conscious State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, controlled cross-over within-subject trial with two arms
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Animal Assisted Occupational Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Animal Assisted Occupational Therapy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Animal Assisted Therapy AAT ergotherapy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rehab Basel

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Fabio Carbone

Doctoral Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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REHAB Basel

Basel, , Switzerland

Site Status RECRUITING

Service de Neurorééducation, Hopitaux Universitaires Genevois

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Fabio Carbone, MSc

Role: CONTACT

Phone: +41612076738

Email: [email protected]

Karin Hediger, Prof

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fabio Carbone

Role: primary

Fabio Carbone

Role: primary

Other Identifiers

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PCEFP1_194591 / 1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-02318

Identifier Type: -

Identifier Source: org_study_id