Clinical trial NCT06270186: Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach
Official title: Feasibility of a Virtual Reality Approach in the Assessment of Executive Functions in Patients With Type 1 Myotonic Dystrophy : Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myotonic Dystrophy 1
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* male or female age ≥ 18
* suffering with type 1 myotonic dystrophy confirmed by molecular biology
* suffering with dysexecutive impairments, with a pathologic BREF score ≤ 15
* affiliated to social security
* able to understand the inform consent form

Exclusion Criteria:

* suffering with visual or auditive impairments preventing them doing tests
* suffering with other pathologies preventing them doing tests
* suffering with motor impairments preventing them holding joysticks or carrying helmet
* protection by law under guardianship, or who cannot participate in a clinical study under Article L. 1121-16 of the French Code of Public Health
* patient under treatment that may affect cognitive functions (ie : Modafinil)
* participation in the last 3 months in a clinical research study in which he / she has been exposed to a pharmaceutical product or a medical device
* pregnant or breastfeeding female patient

Primary outcomes:
measure: Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1
timeFrame: 0 months
Secondary outcomes:
measure: Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session
timeFrame: 0 months
measure: To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session
timeFrame: 0 months
measure: Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests
timeFrame: 0 months
measure: Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session
timeFrame: 0 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Sabrina SACCONI
role: PRINCIPAL_INVESTIGATOR
References: