RecruitingNCT06924125

Spanish Natural History Study for LAMA2 Muscular Dystrophy


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

100 participants

Start Date

Jul 27, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this natural history study is to comprehensively characterize the disease progression and clinical features of LAMA2-related dystrophies (LAMA2-RD) in the pediatric population. The study aims to establish a well-defined cohort of patients in Spain, enabling long-term follow-up and facilitating recruitment for future clinical trials.


Eligibility

Min Age: 0 MinutesMax Age: 100 Years

Inclusion Criteria2

  • All patients with compatible clinical presentation and identification of 2 pathogenic variants in LAMA2, or muscle biopsy with decreased laminin alpha2 protein and at least one pathogenic variant
  • Signed informed consent by the Legal Authority Responsible and/or assent by the subject (starting from 6 years old)

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Interventions

DIAGNOSTIC_TESTMotor function scales

Evaluation of patients motor function using motor scales (MFM32, CHOP)

DIAGNOSTIC_TESTMUSCLE ULTRASOUND

Ultrasound guided evaluation of 28 muscles evaluated accross different body regions, assessed using the Heckmatt gradinf system (semiquantitative scale).

DIAGNOSTIC_TESTMuscle Elastography

Assess the mechanical properties of muscles, such as stiffness and elasticity.

OTHERComplete physical examination

Complete physical evaluations including muscle power and goniometry measurements

OTHERVentilatory/ respiratory and other support assessment

Assessment of ventilatory, respiratory, and other support needs to evaluate the necessity of assistive devices

OTHEROromotor function and nutrition

Assessment of bulbar funcionality: feeding devices, nutritional status.

OTHERMotor Milestone Assessments

Motor milestones age of acquisition and loss


Locations(1)

University Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

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NCT06924125


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