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

Primary Purpose

Myotonic Dystrophy Type 1

Status
Enrolling by invitation
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality-training in Theory of Mind
Traditional training in Theory of Mind
Sponsored by
Institut de Myologie, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myotonic Dystrophy Type 1 focused on measuring Myotonic Dystrophy type 1, Theory of Mind, Virtual environment, Training protocol

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts 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)

Sites / Locations

  • Institut de Psychologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient remediate using the virtual training method

Patient remediate using the traditional training method

Arm Description

Outcomes

Primary Outcome Measures

NEPSY II
Emotion Recognition and Standardized ToM

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2023
Last Updated
September 26, 2023
Sponsor
Institut de Myologie, France
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1. Study Identification

Unique Protocol Identification Number
NCT05916677
Brief Title
Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
Acronym
TOM-VR-DM1
Official Title
Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Myologie, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myotonic Dystrophy Type 1
Keywords
Myotonic Dystrophy type 1, Theory of Mind, Virtual environment, Training protocol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient remediate using the virtual training method
Arm Type
Experimental
Arm Title
Patient remediate using the traditional training method
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Virtual Reality-training in Theory of Mind
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional training in Theory of Mind
Intervention Description
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.
Primary Outcome Measure Information:
Title
NEPSY II
Description
Emotion Recognition and Standardized ToM
Time Frame
Through study completion, an average of 5 weeks
Secondary Outcome Measure Information:
Title
WISC-V
Description
Wechsler Scale is the international benchmark for measuring children's intelligence
Time Frame
Through study completion, on average 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Institut de Psychologie
City
Boulogne-Billancourt
ZIP/Postal Code
92000
Country
France

12. IPD Sharing Statement

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

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