Minimally Conscious State
Conditions
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.
Interventions
PROCEDUREAnimal Assisted Occupational Therapy
AAT is an ergotherapy including an animal. AAT is a specific type of Animal Assisted Intervention (AAI) with a therapeutic aim.
Sponsors
Rehab Basel
University of Basel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled cross-over within-subject trial with two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG signal complexity 3 | Before, during and after AAT and TAU. Approximately three weeks. | 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 |
| EEG signal complexity 2 | Before, during and after AAT and TAU. Approximately three weeks. | 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 |
| EEG signal complexity 1 | Before, during and after AAT and TAU. Approximately three weeks. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other physiological measures 3 | Before, during and after AAT and TAU. Approximately three weeks. | • Electrodermal activity (EDA) in uS |
| Other physiological measures 1 | Before, during and after AAT and TAU. Approximately three weeks. | • Heart rate (HR) in bpm |
| Other physiological measures 2 | Before, during and after AAT and TAU. Approximately three weeks. | • Heart rate variability (HRV) measured by complexity index (CI): score usually between 0 and 1 with higher score indicating higher complexity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Behavioral data assessing state of consciousness 1 | From enrollment to the end of treatment at 2 weeks. Day 1 and last day | • Coma Recovery Scale - Revised (CRS-R): score from 0 to 23 with higher score indicating higher consciousness level |
| Behavioral data assessing state of consciousness 2 | From enrollment to the end of treatment at 2 weeks. Two pre-session measures per week, two post-session measures per week | • Basler Vegetative State Assessment (BAVESTA): 22 items with a score from 0 to 5 with higher total score indicating higher level of consciousness |
Countries
Switzerland
Contacts
Primary ContactFabio Carbone, MSc
Backup ContactKarin Hediger, Prof
Outcome results
None listed