- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341325
Neurovascular Reactions to AAT in Patients With DOC (AAT NIRS)
Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland, 4012
- REHAB Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: animal-assisted intervention
the intervention is a real animal is presented in different forms to the participants
|
a live animal (small dog and/or rabbit)
|
Active Comparator: control intervention
the control intervention is a stuffed toy animal is presented in different forms to the participants
|
a stuffed toy animal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
Time Frame: 2 weeks
|
All parameters are measured in mmol/ml throughout the sessions, measured via NONIN SenSmart
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Galvanic Skin Response
Time Frame: 2 weeks
|
GSR is measured throughout the sessions via ERPrec, an EEG and ERP recording Software.
Skin conductance is measured in μmho.
|
2 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate / heart rate variability
Time Frame: 2 weeks
|
Assessed via ERPrec (photoplethysmography (PPG))
|
2 weeks
|
Basel Vegetative State Assessment (BAVESTA)
Time Frame: 2 weeks
|
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. |
2 weeks
|
Behavioral coding in Noldus Observer
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karin Hediger, Dr. phil., Swiss TPH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAT NIRS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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