NCT02879591

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

July 29, 2016

Last Update Submit

August 24, 2016

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • number of patient enhancing social intercation

    improvement of social interactions (interpersonal relations, items 1 to 7 on Specific Levels Of Functioning, SLOF)

    3 months

Secondary Outcomes (2)

  • number of patient accepting avatar therapy

    3 months

  • questionnaire for Faisability of avatar therapy

    3 months

Study Arms (2)

Patients with schizophrenia

EXPERIMENTAL

Patients with schizophrenia

Other: Social Skills training with Avatar therapist

Healthy volunteers

PLACEBO COMPARATOR

Healthy volunteers

Other: Social Skills training with Avatar therapist

Interventions

Social Skills training with Avatar therapistOTHER
Healthy volunteersPatients with schizophrenia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients suffering from schizophrenia according to the criteria proposed in the DSM-IV-TR
  • Aged between 18 and 60 years old.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Universitaire de psychiatrie adulte, University Hospital of Montpellier

Montpellier, Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Delphine Capdevielle, MD, PhD

CONTACT

0033467339727d-capdevielle@chu-montpellier.Fr

Stéphane Raffard, PhD

CONTACT

0033467339702s-raffard@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 25, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)