Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1 (TOM-VR-DM1)

Institut de Myologie, France

Status: Invitation-only

Conditions: Myotonic Dystrophy Type 1

Treatments: Other: Virtual Reality-training in Theory of Mind; Other: Traditional training in Theory of Mind

Study type: Interventional

Funder types: Other

Identifiers

NCT05916677

TOM-VR-DM1

Details and patient eligibility

About

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.

Enrollment: 95 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Patient remediate using the virtual training method

Experimental group

Treatment:

Other: Virtual Reality-training in Theory of Mind

Patient remediate using the traditional training method

Active Comparator group

Treatment:

Other: Traditional training in Theory of Mind