Neurovascular Reactions to AAT in Patients With DOC (AAT NIRS)
Primary Purpose
Consciousness Disorder, Brain Injuries
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
animal-assisted activity
control activity
Sponsored by
About this trial
This is an interventional treatment trial for Consciousness Disorder focused on measuring animal-assisted therapy
Eligibility Criteria
Inclusion Criteria for patients:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Inpatients of REHAB Basel with severe disorder of consciousness: minimal conscious state defined via: Glasgow Coma Scale (GCS) / Coma Recovery Scale-Revised (Koma Remissions Skala, KRS/KRS-S) / BAVESTA Score
- Minimum Age of 18 years
Inclusion Criteria for healthy participants:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- History of acquired brain-injury
- Minimum age of 18 years
Exclusion Criteria:
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- medical contraindications for contact with animals as allergy, phobia etc.
- If the patient's medication changes radically during the time of data collection (only eligible for clinical participants)
Sites / Locations
- REHAB Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
animal-assisted intervention
control intervention
Arm Description
the intervention is a real animal is presented in different forms to the participants
the control intervention is a stuffed toy animal is presented in different forms to the participants
Outcomes
Primary Outcome Measures
Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
All parameters are measured in mmol/ml throughout the sessions, measured via NONIN SenSmart
Secondary Outcome Measures
Galvanic Skin Response
GSR is measured throughout the sessions via ERPrec, an EEG and ERP recording Software. Skin conductance is measured in μmho.
Full Information
NCT ID
NCT03341325
First Posted
October 4, 2017
Last Updated
September 23, 2021
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Rehab Basel, University of Basel
1. Study Identification
Unique Protocol Identification Number
NCT03341325
Brief Title
Neurovascular Reactions to AAT in Patients With DOC
Acronym
AAT NIRS
Official Title
Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Rehab Basel, University of Basel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There is practical evidence but no scientific investigations that persons with severe disorders of consciousness can profit from animal-assisted therapy regarding their level of awareness.
The aim of this study is to investigate the effect of animal-assisted therapy on brain activity of inpatients at REHAB Basel with severe disorders of consciousness.
To do so, the frontal brain activity of 20 the inpatients at REHAB Basel in a minimally conscious state is investigated via near-infrared spectroscopy (NIRS). Moreover, 20 healthy participants are included as control subjects.
Detailed Description
Each participant will be measured in 6 sessions. Sessions take place three times a week for 2 weeks (leading up to a total of 3 experimental sessions and 3 control sessions), each lasting for about 15 minutes.
Each session consists of 5 phases, with an animal present in three of them. In the beginning, waiting (with no stimulus presented) serves as baseline measurement. Second, an animal is watched, then the animal is placed on the patient's lap and in the fourth condition, the patient can stroke the animal with the help of the present therapist. After, there is again a waiting condition.
Control sessions are comparable sessions but with a fur pet instead of a live animal as stimulus.
Measurements are: brain activity (near-infrared spectroscopy, NIRS), skin conductance (EDA), heart rate and heart rate variability assessed via photoplethysmography (PPG) during the sessions and the BAVESTA score after each session. For further behavior analysis all sessions are videotaped.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorder, Brain Injuries
Keywords
animal-assisted therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
animal-assisted intervention
Arm Type
Experimental
Arm Description
the intervention is a real animal is presented in different forms to the participants
Arm Title
control intervention
Arm Type
Active Comparator
Arm Description
the control intervention is a stuffed toy animal is presented in different forms to the participants
Intervention Type
Other
Intervention Name(s)
animal-assisted activity
Intervention Description
a live animal (small dog and/or rabbit)
Intervention Type
Other
Intervention Name(s)
control activity
Intervention Description
a stuffed toy animal
Primary Outcome Measure Information:
Title
Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
Description
All parameters are measured in mmol/ml throughout the sessions, measured via NONIN SenSmart
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Galvanic Skin Response
Description
GSR is measured throughout the sessions via ERPrec, an EEG and ERP recording Software. Skin conductance is measured in μmho.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Heart rate / heart rate variability
Description
Assessed via ERPrec (photoplethysmography (PPG))
Time Frame
2 weeks
Title
Basel Vegetative State Assessment (BAVESTA)
Description
The BAVESTA generates a score to assess function deficits in patients with severe disorders of consciousness. The scale ranges from 0 to 5 in total with a higher score indicating higher functioning in patients.
Subscales of vegetative regulation, attention, orientation, emotional reactivity, verbal and nonverbal communication, motor activity and information processing are reported.
Time Frame
2 weeks
Title
Behavioral coding in Noldus Observer
Description
All sessions are videotaped and then analyzed via behavioral coding and quantified as count variables. The variables motor activity, eye gaze, emotional reactions and communication are presented as the total number of displayed behavior percentaged to the duration of a session.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients:
Informed Consent as documented by signature (Appendix Informed Consent Form)
Inpatients of REHAB Basel with severe disorder of consciousness: minimal conscious state defined via: Glasgow Coma Scale (GCS) / Coma Recovery Scale-Revised (Koma Remissions Skala, KRS/KRS-S) / BAVESTA Score
Minimum Age of 18 years
Inclusion Criteria for healthy participants:
Informed Consent as documented by signature (Appendix Informed Consent Form)
History of acquired brain-injury
Minimum age of 18 years
Exclusion Criteria:
Enrolment of the investigator, his/her family members, employees and other dependent persons,
medical contraindications for contact with animals as allergy, phobia etc.
If the patient's medication changes radically during the time of data collection (only eligible for clinical participants)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Hediger, Dr. phil.
Organizational Affiliation
Swiss TPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
REHAB Basel
City
Basel
ZIP/Postal Code
4012
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neurovascular Reactions to AAT in Patients With DOC
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