Clinical trial NCT06931665: Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State
Official title: Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Minimally Conscious State
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Rehab Basel
First posted: 2025-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled cross-over within-subject trial with two arms
Primary purpose: TREATMENT

Brief summary: 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: 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)

Primary outcomes:
measure: EEG signal complexity 1
timeFrame: Before, during and after AAT and TAU. Approximately three weeks.
measure: EEG signal complexity 2
timeFrame: Before, during and after AAT and TAU. Approximately three weeks.
measure: EEG signal complexity 3
timeFrame: Before, during and after AAT and TAU. Approximately three weeks.
Secondary outcomes:
measure: Other physiological measures 1
timeFrame: Before, during and after AAT and TAU. Approximately three weeks.
measure: Other physiological measures 2
timeFrame: Before, during and after AAT and TAU. Approximately three weeks.
measure: Other physiological measures 3
timeFrame: Before, during and after AAT and TAU. Approximately three weeks.
Other outcomes:
measure: Behavioral data assessing state of consciousness 1
timeFrame: From enrollment to the end of treatment at 2 weeks. Day 1 and last day
measure: Behavioral data assessing state of consciousness 2
timeFrame: From enrollment to the end of treatment at 2 weeks. Two pre-session measures per week, two post-session measures per week
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