Brain Injuries Clinical Trial
— AAT NIRSOfficial title:
Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
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 |
Verified date | April 2021 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | REHAB Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
Swiss Tropical & Public Health Institute | Rehab Basel, University of Basel |
Switzerland,
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 |
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