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

NCT ID: NCT06270186

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-11-30

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.

Conditions

Myotonic Dystrophy 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Type 1 myotonic dystrophy

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

Group Type: OTHER

Type 1 myotonic dystrophy

Intervention Type: DIAGNOSTIC_TEST

To compare classical neuropsychological test and on "Good Diag NMD" software in Type 1 myotonic dystrophy patients

Interventions

Type 1 myotonic dystrophy

To compare classical neuropsychological test and on "Good Diag NMD" software in Type 1 myotonic dystrophy patients

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabrina SACCONI

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Other Identifiers

20-AOIP-04

Identifier Type: -

Identifier Source: org_study_id