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
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|
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|
|Intervention Model:||Crossover Assignment|
|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|
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
- 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
- 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.
- Heart rate / heart rate variability [ Time Frame: 2 weeks ]Assessed via ERPrec.
- 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.
- 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.
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
|Contact: Karin Hediger, Dr. firstname.lastname@example.org|
|Basel, Switzerland, 4012|
|Contact: Karin Hediger, Dr. phil. 0041 (0)795197885 email@example.com|
|Principal Investigator: Karin Hediger, Dr.|
|Sub-Investigator: Margret Hund-Georgiadis, PD Dr.|
|Principal Investigator:||Karin Hediger, Dr. phil.||Swiss TPH|