Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach (GoodDiagNMD)

Centre Hospitalier Universitaire de Nice

Status: Withdrawn

Conditions: Myotonic Dystrophy 1

Treatments: Diagnostic Test: Type 1 myotonic dystrophy

Study type: Interventional

Funder types: Other

Identifiers

NCT06270186

20-AOIP-04

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Type 1 myotonic dystrophy

Other group

Description:

Type 1 myotonic dystrophy patients doing classical neuropsychological test and on "Good Diag NMD" software

Treatment:

Diagnostic Test: Type 1 myotonic dystrophy