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: Completed
• Conditions: Brain Injuries; Consciousness Disorder
• Intervention / Treatment: Other: animal-assisted activity; Other: control activity

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: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4012
    • REHAB Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Number of Arms

2

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	Other: animal-assisted activity; 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	Other: control activity; 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)	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	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	Assessed via ERPrec (photoplethysmography (PPG))	2 weeks
Basel Vegetative State Assessment (BAVESTA)	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	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

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Rehab Basel; University of Basel
• Investigators: Principal Investigator: Karin Hediger, Dr. phil., Swiss TPH

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: animal-assisted therapy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Consciousness Disorders
• Other Study ID Numbers: AAT NIRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No