Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916677
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-01
First Post:
2023-06-02
Brief Title:
Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
Sponsor:
Institut de Myologie France
Organization:
Institut de Myologie France
Study Overview
Official Title:
Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOM-VR-DM1
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 childs 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None