Enhancing Social Interaction With an AlterEgo Artificial... | NCT02879591

Studies
Enhancing Social Interaction With an AlterEgo Artificial Agent

NCT02879591

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Aug 25, 2016Estimated

Enrollment

246Estimated

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Social Skills training with Avatar therapist

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jul 29, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2016

Last Update Posted Date

Aug 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, MontpellierOTHER

Collaborators

Name	Class
Université Montpellier	OTHER
Ecole Polytechnique Fédérale de Lausanne	OTHER
University of Bristol	OTHER
DEUTSCHES FORSCHUNGSZENTRUM FUER KUENSTLICHE

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

246Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Social Skills training with Avatar therapist	Other		Healthy volunteers Patients with schizophrenia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
number of patient accepting avatar therapy		3 months
questionnaire for Faisability of avatar therapy		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Delphine Capdevielle, MD, PhD	Contact	0033467339727		d-capdevielle@chu-montpellier.Fr
Stéphane Raffard, PhD	Contact	0033467339702		s-raffard@chu-montpellier.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Universitaire de psychiatrie adulte, University Hospital of Montpellier	Recruiting	Montpellier	Montpellier	34295	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided