Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03341325
Other study ID # AAT NIRS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date June 28, 2021

Study information

Verified date April 2021
Source Swiss Tropical & Public Health Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 28, 2021
Est. primary completion date June 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Other:
animal-assisted activity
a live animal (small dog and/or rabbit)
control activity
a stuffed toy animal

Locations

Country Name City State
Switzerland REHAB Basel Basel

Sponsors (3)

Lead Sponsor Collaborator
Swiss Tropical & Public Health Institute Rehab Basel, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate / heart rate variability Assessed via ERPrec (photoplethysmography (PPG)) 2 weeks
Other Basel Vegetative State Assessment (BAVESTA) 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.
2 weeks
Other Behavioral coding in Noldus Observer 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. 2 weeks
Primary 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 Galvanic Skin Response GSR is measured throughout the sessions via ERPrec, an EEG and ERP recording Software. Skin conductance is measured in µmho. 2 weeks
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03400904 - Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
Completed NCT06073145 - Transcranial Doppler Using Wearable Ultrasound Patch
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Recruiting NCT06010823 - Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants N/A
Not yet recruiting NCT05833568 - Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness N/A
Withdrawn NCT04288076 - The Brain and Lung Interaction (BALI) Study N/A
Completed NCT03162484 - Physical Activity and Chronic Acquired Brain Injury N/A
Not yet recruiting NCT02756585 - Computed Tomography Perfusion in Patients With Severe Head Injury N/A
Terminated NCT01430988 - Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury N/A
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A
Completed NCT00975338 - The LETS Study: A Longitudinal Evaluation of Transition Services
Completed NCT00878631 - Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline Phase 2/Phase 3
Completed NCT03166722 - Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition N/A
Not yet recruiting NCT04478812 - Tbit System Precision and Correlation of Different Blood Samples N/A
Recruiting NCT05443542 - VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI N/A
Recruiting NCT05309005 - Virtual Reality and Social Cognition After Acquired Brain Injury
Completed NCT02702635 - Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging N/A
Withdrawn NCT04247321 - Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure N/A
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4