Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270186
Status:
WITHDRAWN
Last Update Posted:
2024-02-21
First Post:
2022-01-14
Brief Title:
Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Feasibility of a Virtual Reality Approach in the Assessment of Executive Functions in Patients With Type 1 Myotonic Dystrophy Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study withdrawn by the sponsor for logistical reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GoodDiagNMD
Brief Summary:
Type 1 myotonic dystrophy MD1 is a genetic and hereditary disease that primarily affects muscle tissue resulting in myotonia difficulty relaxing after contraction and atrophy progressive muscle weakening with decreased muscle volume It also affects eyes heart endocrine system gastrointestinal system and central nervous system Specific cognitive abilities are impaired in patients with MD1 such as attention visio-spatial or visio-building abilities as well as executive dysfunctions
Currently the cognitive assessment of MD1 patients is based on classical neuropsychological tests which are time-consuming and require a MD1 expert neuropsychologist Moreover it is usually very difficult for MD1 patients to accept performing these tests and when they agree to perform them they usually give up before the end This finding is more frequent in MD1 patients with high level of cognitive impairment
In order to overcome these difficulties in assessing cognitive functions of MD1 patients the investigators decided to use innovative tools such as virtual reality which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet glasses and joysticks
The start-up My Cyber Royaume from Lille in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi have developed a software Good Diag NMD which uses virtual reality to assess cognitive disorders more specifically executive functions in patients with type 1 myotonic dystrophy
Currently the cognitive assessment of MD1 patients is based on classical neuropsychological tests which are time-consuming and require a MD1 expert neuropsychologist Moreover it is usually very difficult for MD1 patients to accept performing these tests and when they agree to perform them they usually give up before the end This finding is more frequent in MD1 patients with high level of cognitive impairment
In order to overcome these difficulties in assessing cognitive functions of MD1 patients the investigators decided to use innovative tools such as virtual reality which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet glasses and joysticks
The start-up My Cyber Royaume from Lille in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi have developed a software Good Diag NMD which uses virtual reality to assess cognitive disorders more specifically executive functions in patients with type 1 myotonic dystrophy
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