Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1

Myotonic Dystrophy Type 1 Clinical Trial

— TOM-VR-DM1  

Official title:

Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05916677
• Other study ID #: TOM-VR-DM1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Institut de Myologie, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ability of an individual to conceive some alternative representations and to behave in a flexible manner would emerge from preschool age and drastically improve between the ages of 3 and 5 (Doebel and Zelazo, 2013). They constitute, according to Diamond (2013), a prerequisite for the development of the Theory of Mind (ToM). Deficits in Executive Functions (EF) may therefore interfere with the child's ability to understand and adapt to social situations.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 95
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• 6 years and < 16 years of age

• 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:

• Unable to participate in the study

• Inability to comply with protocol requirements

• Congenital form of DM1

• IQ<70 (Intellectual Disability)

Related Conditions & MeSH terms

• Myotonic Dystrophy
• Myotonic Dystrophy Type 1

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Institut de Psychologie	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Myologie, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEPSY II	Emotion Recognition and Standardized ToM	Through study completion, an average of 5 weeks
Secondary	WISC-V	Wechsler Scale is the international benchmark for measuring children's intelligence	Through study completion, on average 5 weeks