Clinical trial NCT05916677: Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
Official title: Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myotonic Dystrophy Type 1
Keywords: Myotonic Dystrophy type 1
Theory of Mind
Virtual environment
Training protocol
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: NEPSY II
timeFrame: Through study completion, an average of 5 weeks
Secondary outcomes:
measure: WISC-V
timeFrame: Through study completion, on average 5 weeks
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Institut de Psychologie
Study officials:
References: