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

NCT05916677 | Unknown

• 1 other identifier: TOM-VR-DM1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Myotonic Dystrophy Type 1

Keywords

Myotonic Dystrophy type 1; Theory of Mind; Virtual environment; Training protocol

Outcome Measures

Primary Outcomes (1)

• NEPSY II

  Emotion Recognition and Standardized ToM

  Through study completion, an average of 5 weeks

Secondary Outcomes (1)

• WISC-V

  Through study completion, on average 5 weeks

Study Arms (2)

Patient remediate using the virtual training method

EXPERIMENTAL

Other: Virtual Reality-training in Theory of Mind

Patient remediate using the traditional training method

ACTIVE COMPARATOR

Other: Traditional training in Theory of Mind

Interventions

Virtual Reality-training in Theory of Mind OTHER

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 virtual training method

Traditional training in Theory of Mind OTHER

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.

Patient remediate using the traditional training method

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Myologie, France: lead

Study Sites (1)

Institut de Psychologie

Boulogne-Billancourt, 92000, France

Location

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 23, 2023
• Study Start: October 30, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

FR (1)