Actively Recruiting
Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study
Led by University of Basel · Updated on 2025-12-18
26
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Basel
Lead Sponsor
R
Rehab Basel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Animal Assisted Therapy (AAT) on brain signal complexity in patients with a minimally conscious state (MCS). MCS patients typically show lower brain complexity compared to healthy individuals, measured by electroencephalogram (EEG) entropy. The study investigates whether AAT can increase this complexity, which is important for understanding consciousness levels. In addition, electrocardiography (ECG), electrodermal activity (EDA), and behavioral measures will be collected to provide a broader view of physiological changes. Participants will take part in two therapy sessions per week within their clinical routine, totaling four sessions. The study uses a randomized, controlled cross-over design with two arms: one starting with AAT followed by treatment as usual (TAU), and the other starting with TAU followed by AAT. Each patient experiences both interventions in alternating weeks, allowing comparison of effects between the therapies. During the approximately three-week study period, EEG signal complexity will be measured before, during, and after both AAT and TAU sessions. Other physiological measures like ECG and EDA will also be monitored alongside behavioral assessments. The study tracks changes in brain activity and physiological responses to evaluate the impact of AAT. Participants are closely observed throughout, ensuring safety and adherence to the protocol.
CONDITIONS
Brief Title
Neurological and Physiological Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inpatients at one of the study sites
- Acquired brain injury from traumatic or non-traumatic events
- Diagnosis of minimally conscious state defined by CRS-R and Aspen criteria
- Informed consent signed by the patient's legal representative
- Physiologically stable condition
- Age 18 years or older
You will not qualify if you...
- Phobia or allergies to animals involved in therapy
- Acute or chronic medical conditions such as chronic pain, hypertension, heart disease, kidney disease, liver disease, or diabetes
- Recent major changes in medication decided by the responsible physician
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 weeks
Participants receive two therapy sessions per week for two weeks. These sessions include Animal Assisted Occupational Therapy (AAT) and Treatment As Usual (TAU) in a randomized cross-over design integrated into their clinical routine.
4 therapy sessions over 2 weeks (in-person)
Trial Site Locations
Total: 2 locations
1
REHAB Basel
Basel, Switzerland
Actively Recruiting
2
Service de Neurorééducation, Hopitaux Universitaires Genevois
Geneva, Switzerland
Actively Recruiting
Research Team
F
Fabio Carbone, MSc
K
Karin Hediger, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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