SchizophreniaALTEREGONCT02879591
Enhancing Social Interaction With an AlterEgo Artificial Agent
A study testing Social Skills training with Avatar therapist in people with Schizophrenia, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social Skills training with Avatar therapist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients suffering from schizophrenia according to the criteria proposed in the DSM-IV-TR
- Aged between 18 and 60 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Universitaire de psychiatrie adulte, University Hospital of Montpellier
Montpellier, Montpellier, 34295
Delphine Capdevielle, 0033467339727, d-capdevielle@chu-montpellier.fr
Stéphane Raffard, PhD, 0033467339702, s-raffard@chu-montpellier.fr
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- Social Skills training with Avatar therapist
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Skills training with Avatar therapistOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Experimental | Patients with schizophrenia Receives: Other: Social Skills training with Avatar therapist |
| Healthy volunteers | Placebo comparator | Healthy volunteers Receives: Other: Social Skills training with Avatar therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient enhancing social intercation
improvement of social interactions (interpersonal relations, items 1 to 7 on Specific Levels Of Functioning, SLOF)
Measured: 3 months
Secondary outcomes (2)
number of patient accepting avatar therapy
Measured: 3 months
questionnaire for Faisability of avatar therapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier, Ecole Polytechnique Fédérale de Lausanne, University of Bristol, DEUTSCHES FORSCHUNGSZENTRUM FUER KUENSTLICHE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879591
- Sponsor's protocol ID
- U 9038
- Acronym
- ALTEREGO
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Social Interaction With an AlterEgo Artificial Agent
- ClinicalTrials.gov ID
- NCT02879591
- Acronym / sponsor ID
- ALTEREGO / U 9038
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier, Ecole Polytechnique Fédérale de Lausanne, University of Bristol, DEUTSCHES FORSCHUNGSZENTRUM FUER KUENSTLICHE
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Experimental | Other: Social Skills training with Avatar therapistPatients with schizophrenia |
| Healthy volunteers | Placebo comparator | Other: Social Skills training with Avatar therapistHealthy volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients suffering from schizophrenia according to the criteria proposed in the DSM-IV-TR
- Aged between 18 and 60 years old.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Skills training with Avatar therapist | Other | Healthy volunteers, Patients with schizophrenia |
Primary outcome
number of patient enhancing social intercation
Time frame: 3 months
improvement of social interactions (interpersonal relations, items 1 to 7 on Specific Levels Of Functioning, SLOF)
2 secondary outcomes
number of patient accepting avatar therapy
Time frame: 3 months
questionnaire for Faisability of avatar therapy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Skills training with Avatar therapist in people with Schizophrenia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delphine Capdevielle, MD, PhD (0033467339727, d-capdevielle@chu-montpellier.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patient enhancing social intercation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.