An interventional study of Animal Assisted Occupational Therapy in Minimally Conscious State, sponsored by University of Basel. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of Basel · Not applicable, Interventional, and Treatment
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.
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's planned enrollment of 26 is below the median of 30 across 55 interventional studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →University of Basel is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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.
Procedure: Animal Assisted Occupational Therapy
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.
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.
Also known as: Animal Assisted Therapy, AAT, ergotherapy
EEG signal complexity 1
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
Time frame: Before, during and after AAT and TAU. Approximately three weeks.
EEG signal complexity 2
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
Time frame: Before, during and after AAT and TAU. Approximately three weeks.
EEG signal complexity 3
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
Time frame: Before, during and after AAT and TAU. Approximately three weeks.
Other physiological measures 1
• Heart rate (HR) in bpm
Time frame: Before, during and after AAT and TAU. Approximately three weeks.
Other physiological measures 2
• Heart rate variability (HRV) measured by complexity index (CI): score usually between 0 and 1 with higher score indicating higher complexity
Time frame: Before, during and after AAT and TAU. Approximately three weeks.
Other physiological measures 3
• Electrodermal activity (EDA) in uS
Time frame: Before, during and after AAT and TAU. Approximately three weeks.
Behavioral data assessing state of consciousness 1
• Coma Recovery Scale - Revised (CRS-R): score from 0 to 23 with higher score indicating higher consciousness level
Time frame: From enrollment to the end of treatment at 2 weeks. Day 1 and last day
Behavioral data assessing state of consciousness 2
• Basler Vegetative State Assessment (BAVESTA): 22 items with a score from 0 to 5 with higher total score indicating higher level of consciousness
Time frame: From enrollment to the end of treatment at 2 weeks. Two pre-session measures per week, two post-session measures per week
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Apr 2027, 21 months after the start.
Of 23 interventional studies with no phase under Persistent Vegetative State, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's planned 21 months is below that.
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