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| ID | Type | Description | Link |
|---|---|---|---|
| PCEFP1_194591 / 1 | Other Grant/Funding Number | Swiss National Science Foundation |
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| Name | Class |
|---|---|
| Rehab Basel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAT-TAU-AAT-TAU (arm 1) | Experimental | 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. |
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| TAU-AAT-TAU-AAT (arm 2) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animal Assisted Occupational Therapy | Procedure | AAT is an ergotherapy including an animal. AAT is a specific type of Animal Assisted Intervention (AAI) with a therapeutic aim. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Before, during and after AAT and TAU. Approximately three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Other physiological measures 1 | • Heart rate (HR) in bpm | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 2 weeks. Day 1 and last day |
| Behavioral data assessing state of consciousness 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Carbone, MSc | Contact | +41612076738 | fabio.carbone@unibas.ch | |
| Karin Hediger, Prof | Contact | karin.hediger@unilu.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| REHAB Basel | Recruiting | Basel | Switzerland |
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| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056447 | Animal Assisted Therapy |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Randomized, controlled cross-over within-subject trial with two arms
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| Before, during and after AAT and TAU. Approximately three weeks. |
| Other physiological measures 3 | • Electrodermal activity (EDA) in uS | Before, during and after AAT and TAU. Approximately three weeks. |
• Basler Vegetative State Assessment (BAVESTA): 22 items with a score from 0 to 5 with higher total score indicating higher level of consciousness |
| From enrollment to the end of treatment at 2 weeks. Two pre-session measures per week, two post-session measures per week |
| Service de Neurorééducation, Hopitaux Universitaires Genevois | Recruiting | Geneva | Switzerland |
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| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |