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Social Cognition in Dystrophinopathies and Neurodevelopmental Disorders

ConditionsDuchenne / Becker Muscular DystrophyOsteogenesis Imperfecta (OI)Social Cognition
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age4+
SponsorIRCCS Eugenio Medea

About this trial

The primary aim of this observational study is to investigate specific aspects of social cognition in dystrophinopathies. Body awareness, interpersonal distance and emotional processing will be measured in a sample of patients affected by Becker (BMD) and Duchenne (DMD) muscular dystrophy, compared with a sample of patients affected by osteogenesis imperfecta (OI), and both compared with a control sample with typical development.

The secondary aim is to study cortical activity at rest, by means of electroencephalography (EEG), to explore frequencies and time course of EEG responses. Moreover, the relationship between EEG activity and neuropsychological, dispositional and subjective measures will be explored through correlational analyses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients diagnosed with Duchenne and Becker muscular dystrophy (genetic and histological diagnosis and clinical diagnosis) (ambulant and non-ambulant).

Patients diagnosed with osteogenesis imperfecta.

Control group: participants without any neurological or psychiatric disorder

Disqualifiers

presence of comorbid diagnoses,

sensory deficit

specific condition that could prevent the application of the tests and tasks under study, such as: a) the need for PEG; b) the need for tracheostomy; c) the need for assisted ventilation.

cognitive level lower than 60.

Trial population

For the statistical power analysis the size of the effect reported in Candini et al., 2017 (η2p = 0.28) has been considered, about the effect of diagnostic features on the peripersonal space, and the effect reported by Garcia et al., 2023 (η2p = 0.20) about the differences between DMD/BMD patients and neurotypicals in social cognition. The calculation, performed separately for the two different effects, returns a sample size between 17 and 23 minimum patients per group.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Electroencephalography (EEG)

    Other intervention

    Recording of resting state EEG will be collected

  • Social Cognition Tasks

    Other intervention

    Comfort-Distance Task: it will be used to measure the interpersonal comfort distance, the task will be implemented in immersive virtual reality environment Interoception will be measured through an auditory match task based on participants heart-beat A measure emotion processing will be collected through the emotion priming visual task, participants will be asked to detect trial by trial the target emotion which could be preceded by a congruent or incongruent visual priming

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: BMD/DMD group2 interventions
Group B: OI group2 interventions
Group C: Control group2 interventions

Trial outcomes

Primary outcomes

1

Interoception

interoceptive index

Time frame
Day 1
2

Interpersonal distance

Interpersonal comfort distance, measured in meters (m) within the virtual environment

Time frame
Day 1
3

Emotional processing

Visual priming task performance

Time frame
Day 1
4

EEG power

EEG alpha power

Time frame
once

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Eugenio Medea

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: