An observational study in Duchenne / Becker Muscular Dystrophy, Osteogenesis Imperfecta (OI) and Social Cognition, sponsored by IRCCS Eugenio Medea. Not yet recruiting. Open to male participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by IRCCS Eugenio Medea · Observational
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.
Study procedure includes: 1. Eligibility assessment according to inclusion and exclusion criteria. 2. Administration of questionnaires and scales for the characterization of cognitive and psychological features related with BMD/DMD and OI : Wechsler Intelligence Scale for Children 4th Edition (WISC-IV), Raven's Progressive Matrices; NEPSY-II; The Child Behavior Checklist (CBCL); PedsQL; Toronto Alexithymia Scale (TAS-20); Emotion Regulation Questionnaire (ERQ); Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA); Multidimensional Assessment of Interoceptive Awareness (MAIA); Body Shape Questionnaire (BSQ-14); and the Autism Spectrum Quotient (AQ, adult or child version) 3. Administration of experimental tasks. The Comfort-Distance Task (CDT) to measure the interpersonal comfort distance, the task will be implemented in immersive virtual reality by means of head-mounted displays (OCULUS ©2024 Meta). Interoceptive accuracy will be measured through a modified version of the heartbeat counting task. An emotional priming task will be administered in order to measure emotion processing, participants will be asked to detect trial by trial the target emotion which could be preceded by a congruent or incongruent visual priming.
All the tasks will be performed in a counterbalanced order, for an overall duration of about 40 minutes.
481 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 108 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 132 observational studies indexed under Muscular Dystrophy, Duchenne.
Browse Muscular Dystrophy, Duchenne studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 51 are open to participants now.
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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.
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Exclusion Criteria:
Patients diagnosed with Duchenne and Becker muscular dystrophy (genetic and histological diagnosis and clinical diagnosis) (ambulant and non-ambulant), over the age of four.
Other: Electroencephalography (EEG) · Other: Social Cognition Tasks
Patients diagnosed with osteogenesis imperfecta, over the age of four.
Other: Electroencephalography (EEG) · Other: Social Cognition Tasks
Participants without any neurological or psychiatric disorder, over the age of four.
Other: Electroencephalography (EEG) · Other: Social Cognition Tasks
Recording of resting state EEG will be collected
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
Interoception
interoceptive index
Time frame: Day 1
Interpersonal distance
Interpersonal comfort distance, measured in meters (m) within the virtual environment
Time frame: Day 1
Emotional processing
Visual priming task performance
Time frame: Day 1
EEG power
EEG alpha power
Time frame: once
EEG power
EEG beta power
Time frame: Day 1
EEG power
EEG theta power
Time frame: Day 1
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Sep 2027, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Muscular Dystrophy, Duchenne →