Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
NCT ID: NCT05916677
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
95 participants
INTERVENTIONAL
2023-10-30
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Treatment failures are often observed when traditional cognitive tools are used. This would be linked to the divergence between non-immersive tests and situations encountered in everyday life (Damasio, 1994; Priore Castelnuovo and Liccione, 2002). For this reason, an increasing number of researchers are using virtual reality for the rehabilitation of executive functions and Theory of Mind in patients with neurodevelopmental pathology (Millen, Edlin-White and Cobb, 2010) or brain damage (Le Gall, Besnard, Louisy, Richard and Allain 2008). There is currently no systematic evaluation of ToM in children with the infantile form of DM1 even though these abilities are considered particularly vulnerable and have a decisive impact on the subsequent development of interpersonal relationships.
This research will focus on studying the socio-emotional disorders associated with the infantile form of Myotonic Dystrophy type 1 (DM1). The axis that we propose to develop more specifically will be an interventional study with the aim of remediation with children from 5 to 16 years old suffering from the infantile form of DM1 via a training protocol in low-immersion Virtual Reality (VR) centered on emotional processing and theory of mind.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patient remediate using the virtual training method
Virtual Reality-training in Theory of Mind
Two social scenarios will be used in a virtual environement. Experimenter and subject participate in the scenario as friends of the main character, Nicolas. During the training session, experimenter asks structured questions about participant's awareness of a mental state. In the case of a wrong answer, a feedback-correction is provided via the avatar's thought bubbles. The participant has access to all avatars thought bubbles. In this way, he is able to compare the desires, beliefs or false beliefs of each story character.
Participants included in this condition will also have an eye-tracking assessment before and after the training procedure.
Patient remediate using the traditional training method
Traditional training in Theory of Mind
The same two social scenarios are presented to the participant in a story-telling form. Participant has access to thought bubbles via an illustrated book. These trainings will take place in the same number of sessions and took place for a duration equivalent to those used in low immersion Virtual Reality mode. Each training session (EFB, BE, SOFB, ERA, FP, EFP) will be illustrated via visual aids taken from screenshots of the two virtual environments and the target protagonists.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Reality-training in Theory of Mind
Two social scenarios will be used in a virtual environement. Experimenter and subject participate in the scenario as friends of the main character, Nicolas. During the training session, experimenter asks structured questions about participant's awareness of a mental state. In the case of a wrong answer, a feedback-correction is provided via the avatar's thought bubbles. The participant has access to all avatars thought bubbles. In this way, he is able to compare the desires, beliefs or false beliefs of each story character.
Participants included in this condition will also have an eye-tracking assessment before and after the training procedure.
Traditional training in Theory of Mind
The same two social scenarios are presented to the participant in a story-telling form. Participant has access to thought bubbles via an illustrated book. These trainings will take place in the same number of sessions and took place for a duration equivalent to those used in low immersion Virtual Reality mode. Each training session (EFB, BE, SOFB, ERA, FP, EFP) will be illustrated via visual aids taken from screenshots of the two virtual environments and the target protagonists.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent
* Affiliate or beneficiary of a social security scheme
* Able to comply with all protocol requirements
* Infantile form of DM1 with molecular confirmation.
* Development without incident in the first year
* Normal development in the pre and neonatal period
* Native language French
Exclusion Criteria
* Inability to comply with protocol requirements
* Congenital form of DM1
* IQ\<70 (Intellectual Disability)
6 Years
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut de Myologie, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut de Psychologie
Boulogne-Billancourt, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOM-VR-DM1
Identifier Type: -
Identifier Source: org_study_id