Clinical trial NCT03341325: Neurovascular Reactions to AAT in Patients With DOC
Official title: Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consciousness Disorder
Brain Injuries
Keywords: animal-assisted therapy
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Rehab Basel
name: University of Basel
First posted: 2017-11-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
timeFrame: 2 weeks
Secondary outcomes:
measure: Galvanic Skin Response
timeFrame: 2 weeks
Other outcomes:
measure: Heart rate / heart rate variability
timeFrame: 2 weeks
measure: Basel Vegetative State Assessment (BAVESTA)
timeFrame: 2 weeks
measure: Behavioral coding in Noldus Observer
timeFrame: 2 weeks
Locations:
city: Basel
country: Switzerland
facility: REHAB Basel
Study officials:
affiliation: Swiss TPH
name: Karin Hediger, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References: