Neurovascular Reactions to AAT in Patients With DOC

NCT03341325 | Completed

• 1 other identifier: AAT NIRS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Consciousness Disorder; Brain Injuries

Keywords

animal-assisted therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Galvanic Skin Response

  2 weeks

Other Outcomes (3)

• Heart rate / heart rate variability

  2 weeks

• Basel Vegetative State Assessment (BAVESTA)

  2 weeks

• Behavioral coding in Noldus Observer

  2 weeks

Study Arms (2)

animal-assisted intervention

EXPERIMENTAL

the intervention is a real animal is presented in different forms to the participants

Other: animal-assisted activity

control intervention

ACTIVE COMPARATOR

the control intervention is a stuffed toy animal is presented in different forms to the participants

Other: control activity

Interventions

animal-assisted activity OTHER

a live animal (small dog and/or rabbit)

animal-assisted intervention

control activity OTHER

a stuffed toy animal

control intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed Consent as documented by signature (Appendix Informed Consent Form)
• History of acquired brain-injury
• Minimum age of 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Rehab Basel: collaborator
• University of Basel: collaborator

Study Sites (1)

REHAB Basel

Basel, 4012, Switzerland

Location

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Karin Hediger, Dr. phil.

  Swiss TPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 14, 2017
• Study Start: February 1, 2017
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-04

Locations

CH (1)