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An International Federated Model for Wearable-derived Remote Longitudinal Motor Monitoring in Young Children With Spinal Muscular Atrophy Compared With Healthy Controls: Active-NBS Study (UK)

Recruitingn/aAges any - 4 YearsAllUniversity of Oxford
NCT07543003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Active-NBS is a study to evaluate the muscle development of patients with spinal muscular atrophy (SMA) who are diagnosed at birth. Medicines have become available in the last decade, and many patients are treated very early. Treatments are most effective if used before the patient develops symptoms. However, some patients may show symptoms by the time they receive treatment. This means that even with early diagnosis, they might still develop muscle weakness despite treatment. The investigators want to see when the movements of patients diagnosed at birth differ from normal development. This information will help identify the best time to give additional medicines currently being developed to support the muscle. The investigators will track the progress of up to 60 patients over a maximum of 30 months using wearable technologies which are worn at home. The investigators aim to validate

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📋 Eligibility rules (as published)
Inclusion criteria (Test cohort): 1. Genetically confirmed SMA and number of SMN2 copies available 2. a. Patients identified by NBS and treated with disease modifying therapy (DMT) (2)a,i 4 copies or more of SMN2 and not treated with DMT (2)a,ii less than 4 copies of SMN2 and not treated with DMT or (2)b. Patients diagnosed due to a sibling or alternative means (2)b,i 4 copies or more of SMN2 and not treated with DMT (2)b,ii less than 4 copies of SMN2 and not treated with DMT (3)Patients between 4 months and below 4 years at baseline. Inclusion of patients can be before 4 months of age (4)Parent(s)/legal guardian(s) able to provide written informed consent prior to the patient's participation in the study (5)Male or female Exclusion Criteria (Test cohort): 1. Any acute or chronic condition which, according to the investigator, significantly interferes with the assessments and/or the motor evolution 2. Currently enrolled in an experimental treatment study Inclusion criteria (Control): 1. Typically developing child 2. Participant between 6 months and 4 years at inclusion 3. Parent(s)/legal guardian(s) able to provide written informed consent prior to the participation in the study 4. Male or female Exclusion criteria (Control): (1)Any acute or chronic condition which, according to the investigator, significantly interferes with the assessments and/or the motor evolution
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What it tests

  • Not listed
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Where

1 site
University of Oxford
Oxford, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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