Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Animal Assisted Occupational Therapy.
- Who it may be relevant to
- Registry conditions: Minimally Conscious State. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- EEG signal complexity 1 [Time frame: Before, during and after AAT and TAU. Approximately three weeks.]
- EEG signal complexity 2 [Time frame: Before, during and after AAT and TAU. Approximately three weeks.]
- EEG signal complexity 3 [Time frame: Before, during and after AAT and TAU. Approximately three weeks.]
Secondary outcome measures (3)
- Other physiological measures 1 [Time frame: Before, during and after AAT and TAU. Approximately three weeks.]
- Other physiological measures 2 [Time frame: Before, during and after AAT and TAU. Approximately three weeks.]
- Other physiological measures 3 [Time frame: Before, during and after AAT and TAU. Approximately three weeks.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- REHAB Basel — Basel
- Service de Neurorééducation, Hopitaux Universitaires Genevois — Geneva
Identifiers
NCT: NCT06931665 · 2024-02318 · PCEFP1_194591 / 1