Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Trial code
- Status
- Withdrawn
- Started
- Nov 2023
- Ended
- Nov 2024
- Type of study
- Interventional
- Treatments tested
- Type 1 myotonic dystrophy
- Record updated
- 21 February 2024
- Why it stopped
- study withdrawn by the sponsor for logistical reasons
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Type 1 myotonic dystrophyOther group
Type 1 myotonic dystrophy patients doing classical neuropsychological test and on "Good Diag NMD" software
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility of a Virtual Reality Approach in the Assessment of Executive Functions in Patients With Type 1 Myotonic Dystrophy : Pilot Study
- Record updated
- 21 February 2024