Status:
COMPLETED
Virtual Reality Intervention for the Reduction of Behavioral and Psychological Symptoms of Dementia
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Dementia
Alzheimer's Disease
Eligibility:
All Genders
60-100 years
Phase:
NA
Brief Summary
Alzheimer's disease and related disorders (AD2) are characterised by cognitive changes and Behavioural and Psychological Symptoms of Dementia (BPSD). According to the French National Authority for Hea...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participants will have to present a NPI score of 9 or more on at least one of the following items : apathy, agitation, anxiety, depression, aberrant motor behavior.
- The behavioural disorders do not prevent the participation in a session.
- For participants able to give consent:
- Written informed consent to participate in the study
- Informed consent of the participant in the presence of his/her curator for participant under curatorship.
- For participants who are not able to receive information and to give consent:
- Written informed consent of the legal representative (tutor) for participants under tutelage.
- Signature of a relative (family member and/or trusted person) of the participant
- The participant has to be affiliated to a social security scheme.
- Exclusion Criteria :
- Unstable pathology whose nature may interfere with the assessment variables:
- Neurological disorder of infectious origin
- Psychiatric disorder
- Substance abuse
- Severe uncompensated sensory deficit
- History of epilepsy
- Pacemaker or severe and/or uncontrolled heart disease (at the discretion of the investigator)
- Visual hallucinations
- Burns and sores on the upper face or scalp
- Unable to express their consent, without a trusted person (family or close friend) and not legally protected
Exclusion
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04769024
Start Date
December 2 2022
End Date
March 4 2024
Last Update
December 3 2024
Active Locations (6)
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1
EHPAD du Centre Hospitalier du Pays de Craponne Sur Arzon
Craponne-sur-Arzon, France, 43500
2
EHPAD du Centre Hospitalier Emile Roux
Le Puy-en-Velay, France, 43000
3
EHPAD Saint-Joseph
Le Puy-en-Velay, France, 43000
4
EHPAD Maison Saint-François d'Assise Lyon
Lyon, France, 69001