Neurovascular Reactions to AAT in Patients With DOC

Not Applicable

Completed

• Conditions: Consciousness Disorder; Brain Injuries
• Interventions: Other: animal-assisted activity; Other: control activity

• Registration Number: NCT03341325
• Lead Sponsor: Swiss Tropical & Public Health Institute

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-14
• Status Verified: 2021-04
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
animal-assisted intervention	animal-assisted activity	the intervention is a real animal is presented in different forms to the participants
control intervention	control activity	the control intervention is a stuffed toy animal is presented in different forms to the participants

Primary Outcome Measures

Name	Time	Method
Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)	2 weeks	All parameters are measured in mmol/ml throughout the sessions, measured via NONIN SenSmart

Secondary Outcome Measures

Name	Time	Method
Galvanic Skin Response	2 weeks	GSR is measured throughout the sessions via ERPrec, an EEG and ERP recording Software. Skin conductance is measured in μmho.

Trial Locations

Locations (1)

REHAB Basel; 🇨🇭 Basel, Switzerland