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Completed

NCT Number: NCT03341325

Neurovascular Reactions to AAT in Patients With DOC

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

animal-assisted activity

Other

a live animal (small dog and/or rabbit)

control activity

Other

a stuffed toy animal

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. Heart rate / heart rate variability

    Time frame: 2 weeks

    Assessed via ERPrec (photoplethysmography (PPG))

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Rehab Basel
  • University of Basel

Registry information

Official study title

Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial

Acronym: AAT NIRS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2017
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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