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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02879591
Other study ID # U 9038
Secondary ID
Status Recruiting
Phase N/A
First received July 29, 2016
Last updated August 24, 2016
Start date April 2014
Est. completion date September 2016

Study information

Verified date August 2016
Source University Hospital, Montpellier
Contact Delphine Capdevielle, MD, PhD
Phone 0033467339727
Email d-capdevielle@chu-montpellier.Fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The objective of AlterEgo is the creation of an interactive cognitive architecture, implementable in various artificial agents, allowing a continuous interaction with patients suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as morphological (avatar-based) properties of that agent. The project includes research in fundamental and clinical neurosciences, interaction modeling, development of new computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios with patients before, during, and after training sessions. At the end of the project, the investigators will produce a new avatar-based clinical method able to enhance social interaction of patients.

The first challenge of this project is to create an avatar alter ego of a patient. Based on recent work in social robotics and neurosciences, the investigators hypothesize that if patients face artificial agents morphologically and behaviourally similar to them, they will increase their social interaction. The second challenge is to transform the morphology and the behaviour of the similar artificial agent into that of a healthy and different agent. The investigators assume that the smooth and continuous behavioural shift from similar/unhealthy to complementary/healthy social behaviour will lead to a better social rehabilitation. AlterEgo opens the door to a new generation of social artificial agents in service robotics. AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and Psychiatry (CHU).

This project includes a set of experiments that started in april 2014 and will terminate in september 2016 before undergoing a randomised clinical research.


Recruitment information / eligibility

Status Recruiting
Enrollment 246
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients suffering from schizophrenia according to the criteria proposed in the DSM-IV-TR

- Aged between 18 and 60 years old.

Exclusion Criteria:

- History of head trauma

- History of neurological disorders (epilepsy disease, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, stroke)

- An actual ECT treatment

- Substance Abuse and / or current Substance dependence (excluding tobacco and cannabis).

- Pregnant women, new mothers and nursing mothers

- People private of their liberty

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Social Skills training with Avatar therapist


Locations

Country Name City State
France Service Universitaire de psychiatrie adulte, University Hospital of Montpellier Montpellier

Sponsors (5)

Lead Sponsor Collaborator
University Hospital, Montpellier DEUTSCHES FORSCHUNGSZENTRUM FUER KUENSTLICHE, École polytechnique fédérale de Lausanne, Université Montpellier, University of Bristol

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patient enhancing social intercation improvement of social interactions (interpersonal relations, items 1 to 7 on Specific Levels Of Functioning, SLOF) 3 months No
Secondary number of patient accepting avatar therapy 3 months No
Secondary questionnaire for Faisability of avatar therapy 3 months No
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