RecruitingNCT07488806

Natural History Study for Patients With Nemaline Myopathy in Spain


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

100 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this natural history study is to comprehensively characterize the disease progression and clinical features of nemaline myopathies. 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

Inclusion Criteria2

  • Patients with a confirmed clinical and genetic diagnosis of MN (mutations in ACTA1, NEB, TPM2, TPM3, KBTBD13, CFL2, KLHL40, KLHL41, LMOD3, MYPN, TNNT1, TNNT3), or under discussion if they only have a compatible biopsy.
  • Signed informed consent by the patient or Legal Authority Responsible, and/or assent by the subject (in pediatric population).

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Interventions

DIAGNOSTIC_TESTMuscle Ultrasound

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

DIAGNOSTIC_TESTMotor function scales

Evaluation of patients motor function using motor scales (CHOP-INTEND, MFM32, HINE-2, NSAA, PDSM-3, RFF, 10m walk, PUL)

OTHERComplete physical examination

Complete physical evaluations including muscle power and goniometry measurements

OTHERVentilatory/ respiratory, Cardiac and other support assessment

Assessment of ventilatory, cardiac, nutritional, and other support needs

OTHERQOL assessment, Neuropsychological

Assessment of quality of life

DEVICEDigital Biomarkers

Video/photos with the aim is to record actions such as lifting a glass, raising arms above the head, getting up from the floor or a chair, walking, or running, in order to later analyze in detail how these movements are performed.

OTHEROromotor function and nutrition

Assessment of bulbar funcionality: feeding devices, nutritional status.

OTHERMotor Milestone Assessments

Motor milestones age of acquisition and loss (if applicable)


Locations(1)

University Hospital Vall d'Hebron

Barcelona, Spain

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NCT07488806


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