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

NCT06270186 | Withdrawn

• 1 other identifier: 20-AOIP-04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1

  The feasibility "Good Diag NMD" software in patient with type 1 myotonic dystrophy (DM1) will be determined as the rate of patients having completed the Good Diag NMD session in full. Satisfactory feasibility is considered if this rate of patients is greater or equal to 50%.

  0 months

Secondary Outcomes (4)

• Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session

  0 months

• To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session

  0 months

• Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests

  0 months

• Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session

  0 months

Study Arms (1)

Type 1 myotonic dystrophy

OTHER

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

Diagnostic Test: Type 1 myotonic dystrophy

Interventions

Type 1 myotonic dystrophy DIAGNOSTIC_TEST

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

Type 1 myotonic dystrophy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sabrina SACCONI

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 21, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share