An observational study in Becker Muscular Dystrophy, sponsored by Institut de Myologie, France. Not yet recruiting at 1 site in France. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Institut de Myologie, France · Observational
Monitoring patients with neuromuscular disorders is crucial but doesn't always allow for a sufficiently specific approach to all aspects of the condition. However, in the event of future treatment, it is essential for clinical and research teams to have as much information as possible about the disease, particularly regarding its physical, physiological, biological, and neurological aspects.
In this context, it was consider as vital to investigate in greater depth the links between the presence of certain dystrophin isoforms in patients and their potential impacts on cognitive, neurological, and muscular function. The results of this study could serve as a reference for future research and improve the understanding and management of this disease.
All of this data will allow for a precise evaluation of the effects of a potential treatment on the progression of the disease.
481 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 108 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 132 observational studies indexed under Muscular Dystrophy, Duchenne.
Browse Muscular Dystrophy, Duchenne studies →Institut de Myologie, France is the lead sponsor of 30 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fifty patients will be included, including 25 patients having the cerebral Dp140 isoform (Dp140+) and 25 patients lacking the cerebral Dp140 isoform (Dp140-). A same number (n=25) of age-matched healthy volunteers will be included as well.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Individuals with concomitant medical conditions that could interfere with the study outcomes
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dp140+
Dp140-
Brain volume
Measurement of grey and white matter volume (in mm3) using brain MRI sequences.
Time frame: 2 years
Brain cortical thickness
Measurement of cortical thickness (in mm) using brain MRI sequences.
Time frame: 2 years
Brain water motion
Measurement of diffusion-based values, including apparent diffusion coefficient (in m2/s) and fractional anisotropy (unitless) using diffusion-weighted MRI sequences.
Time frame: 2 years
Brain iron metabolism
Measurement of brain iron metabolism using MRI-based quantitative susceptibility mapping (measured in parts per million).
Time frame: 2 years
Brain function: resting-state and following task
Measurement of resting-state brain function (default-mode-network) using functional MRI. Measurement of brain activation using fMRI following fronto-executive task (Stroop test).
Time frame: 2 years
Intelligence test
Evaluation of intelligence using Wechsler Scale of Intelligence (WAIS-4).
Time frame: 2 years
Psychological evaluation of depression
Psychological evaluation using Beck Depression Inventory-II (BDI-II).
Time frame: 2 years
Psychological evaluation of anxiety
Psychological evaluation using State-Trait Anxiety Inventory-2 (STAI-Y2).
Time frame: 2 years
Psychological evaluation of ADHD
Psychological evaluation using Connors Adult Rating Scale.
Time frame: 2 years
Neuropsychological evaluation of memory for attention and cognitive processing
Neuropsychological cognitive evaluation of memory for attention and cognitive processing using Free and Cued Selective Reminding Test (FCSRT).
Time frame: 2 years
Neuropsychological evaluation of visual memory and executive function
Neuropsychological cognitive evaluation of visual memory and executive function using Rey-Osterrieth Complex Figure Test (ROCF).
Time frame: 2 years
Neuropsychological evaluation of visual attention and task switching
Neuropsychological cognitive evaluation of visual attention and task switching using Trail Making Test.
Time frame: 2 years
Neuropsychological evaluation of inhibition
Neuropsychological cognitive evaluation of inhibition using Stroop Color and Word Test.
Time frame: 2 years
Neuropsychological evaluation of verbal functioning
Neuropsychological cognitive evaluation of verbal functioning using Phonemic verbal fluency test.
Time frame: 2 years
Neuropsychological evaluation of facial expressions.
Neuropsychological cognitive evaluation of facial expressions using Pictures of Facial Affect test.
Time frame: 2 years
Neuropsychological evaluation of empathy
Neuropsychological cognitive evaluation understanding inappropriateness, speaker's intentions/motivations, speaker's belief, empathy (participant's ability to know how the character would feel), and finally story comprehension using Faux pas Recognition Test. Empathy is also evaluated using The Interpersonal Reactivity Index.
Time frame: 2 years
Evaluation of muscle disease progression
Evaluation of disease progression based on quantitative assessment of MRI-based muscle fat fraction (FF, in %) and residual muscle (i.e. contractile cross-sectional area, in cm2) in lower limb (individual thigh and leg muscles).
Time frame: 2 years
Evaluation of muscle disease activity (edema, inflammation, ...)
Evaluation of qMRI-biomarkers sensitive to active muscle damage or disease activity such as water T2 and water T1 mapping, expressed in milliseconds (individual thigh and leg muscles).
Time frame: 2 years
Evaluation of muscle extracellular volume
Evaluation of extracellular volume (ECV) in muscle (unitless or %) will be assessed using qMRI-based T1 mapping before and after contrast agent injection (individual thigh and leg muscles).
Time frame: 2 years
Evaluation of energy metabolism.
Evaluation of energy metabolism using qMRI and 31P magnetic resonance spectroscopy.
Time frame: 2 years
Evaluation of intramuscular pH.
Evaluation of intramuscular pH using qMRI and 31P magnetic resonance spectroscopy.
Time frame: 2 years
Evaluation of gait endurance (timed test)
Evaluation of gait endurance using 6-minute walk test (6MWT) and 10-m walking test (10mWT).
Time frame: 2 years
Evaluation of exertion and dyspnea (timed test)
Evaluation of exertion and dyspnea using 30-second sit-to-stand test (30STS).
Time frame: 2 years
Evaluation of TUG test performance
Evaluation of performance at time-up-and-go test (TUG).
Time frame: 2 years
Motor Function assessment
Evaluation of motor function abilities using quantitative Motor Function Measurement (MFM) scale.
Time frame: 2 years
Muscle strength evaluation
Strength evaluation of knee extension/flexion, dorsiflexion/plantarflexion of ankle, hand grip and fingers' pinch strength using dedicated MyoTools.
Time frame: 2 years
Evaluation of quality of life
Evaluation of The "Quality of Life in genetic Neuromuscular Disease" questionnaire (QoL-gNMD).
Time frame: 2 years
Health assessment
Health assessment using the Health Assessment Questionnaire (HAQ).
Time frame: 2 years
Assessment of individual's activity level
Assessment of individual's activity level using Ricci et Gagnon Questionnaire.
Time frame: 2 years
Blood analysis
Evaluation of blood biological parameters.
Time frame: 2 years
Echocardiography
Evaluation of left-ventricular ejection fraction (in %).
Time frame: 2 years
Pulmonary function
Evaluation of Pulmonary Function using Forced Vital Capacity measurement.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
Of 52 non-industry observational studies under Muscular Dystrophy, Duchenne, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 120. This study's planned 36 months is close to that.
Counting every sponsor, half of 63 studies reached it within 40 months; a quarter within 12 and three quarters within 120.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Muscular Dystrophy, Duchenne →
Institut de Myologie, France