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Neurovascular Reactions to AAT in Patients With DOC (AAT NIRS)

S

Swiss Tropical and Public Health (TPH) Institute

Status

Completed

Conditions

Brain Injuries
Consciousness Disorder

Treatments

Other: animal-assisted activity
Other: control activity

Study type

Interventional

Funder types

Other

Identifiers

NCT03341325
AAT NIRS

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

44 participants in 2 patient groups

animal-assisted intervention
Experimental group
Description:
the intervention is a real animal is presented in different forms to the participants
Treatment:
Other: animal-assisted activity
control intervention
Active Comparator group
Description:
the control intervention is a stuffed toy animal is presented in different forms to the participants
Treatment:
Other: control activity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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