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

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ClinicalTrials.gov Identifier: NCT03341325
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : September 28, 2018
Sponsor:
Collaborators:
Rehab Basel
University of Basel
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Consciousness Disorder Brain Injuries Other: animal-assisted activity Other: control activity Not Applicable

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 EKG during the sessions and the BAVESTA score as well as a questionnaire for the investigators after each session. For further behavior analysis all sessions are videotaped.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Heart rate / heart rate variability [ Time Frame: 2 weeks ]
    Assessed via ERPrec.

  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (Koma Remissions Skala, KRS)
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341325


Contacts
Contact: Karin Hediger, Dr. phil. 0041795197885 karin.hediger@unibas.ch

Locations
Switzerland
REHAB Basel Recruiting
Basel, Switzerland, 4012
Contact: Karin Hediger, Dr. phil.    0041 (0)795197885    k.hediger@rehab.ch   
Principal Investigator: Karin Hediger, Dr.         
Sub-Investigator: Margret Hund-Georgiadis, PD Dr.         
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Rehab Basel
University of Basel
Investigators
Principal Investigator: Karin Hediger, Dr. phil. Swiss TPH

Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03341325     History of Changes
Other Study ID Numbers: AAT NIRS
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Tropical & Public Health Institute:
animal-assisted therapy

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders