CClinicalTrials.gg
CompletedNCT05916677TOM-VR-DM1Updated Jun 29, 2026

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

An interventional study of Virtual Reality-training in Theory of Mind and Traditional training in Theory of Mind in Myotonic Dystrophy Type 1, sponsored by Institut de Myologie, France. Completed at 1 site in France. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Institut de Myologie, France · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myotonic Dystrophy Type 1

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Keywords

  • Myotonic Dystrophy type 1
  • Theory of Mind
  • Virtual environment
  • Training protocol
03

In context

Myotonic Dystrophy

125 studies on the registry are indexed under Myotonic Dystrophy; 51 are open to participants now.

This study's enrollment of 35 is below the median of 41 across 66 interventional studies indexed under Myotonic Dystrophy.

Browse Myotonic Dystrophy studies →

Lead sponsor

Institut de Myologie, France is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Unable to participate in the study
  • Inability to comply with protocol requirements
  • Congenital form of DM1
  • IQ\<70 (Intellectual Disability)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Patient remediate using the virtual training method

    Other: Virtual Reality-training in Theory of Mind

  • Active comparator
    Patient remediate using the traditional training method

    Other: Traditional training in Theory of Mind

Interventions

  • OtherVirtual 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.

  • OtherTraditional 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.

06

What researchers measure

Primary outcomes

  1. NEPSY II

    Emotion Recognition and Standardized ToM

    Time frame: Through study completion, an average of 5 weeks

Secondary outcomes

  1. WISC-V

    Wechsler Scale is the international benchmark for measuring children's intelligence

    Time frame: Through study completion, on average 5 weeks

07

Study locations

1 site
  • Institut de Psychologie
    Boulogne-Billancourt, 92000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05916677
Lead sponsor
Institut de Myologie, France
Responsible party
Sponsor
First posted
Jun 23, 2023
Start date
Oct 30, 2023
Primary completion
Jun 28, 2025
Completion
Jun 28, 2025
Last update
Jun 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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