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Evaluation of the Reproducibility of a Fatigability Test Fitted to Patients With Spinal Muscular Atrophy

RecruitingNAAges 6 Years - anyAllCentre Hospitalier Universitaire de Saint Etienne
NCT06562283 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease caused by the degeneration of motor neurons in the anterior horn of the spinal cord, due to the absence of the SMN1 gene and the resulting lack of SMN protein. Some patients with particularly severe forms (types 0 or 1) die before the age of 2 in the absence of treatment, while others retain autonomous walking throughout their lives, with no reduction in life expectancy. Three treatments aimed at restoring SMN (TRS) protein expression have recently been approved by the US Food and Drug Administration and the European Medicines Agency (i.e. Nusinersen / Onasemnogene Abeparvovec / Risdiplam). Patients treated with TRS after the onset of symptoms (symptomatic patients) may show significant motor improvement, but retain difficulties such as muscle weakness and fatigue leading to limitations in activities of daily l

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📋 Eligibility rules (as published)
Inclusion Criteria: * Genetically confirmed spinal muscular atrophy * Age ≥ 6 years * No orthopaedic surgery in the 6 months prior to inclusion * Informed consent signed by the patient(s) or parent(s)/legal guardian(s) and assent of the patient * Affiliated or beneficiary of a health insurance scheme (for inclusion in France) Exclusion Criteria: * Other condition that may significantly interfere with the assessment of the SMA and which is clearly unrelated to the disease * Other associated neurological disease * Joint deformities that prevent correct and comfortable positioning with the various different measuring devices (thumb-index clamp, handgrip and QIF-test) * Contraindication to transcranial magnetic stimulation
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What it tests

  • Thumb test
  • Grip test
  • Quadriceps Intermittent Fatigue test (QIF test))
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Where

4 sites
Unités de Myologie et de Médecine du Sport
Saint-Etienne, France
HCL - Hôpital Croix Rousse
Lyon, France
HFME - Hospices Civils de Lyon
Lyon, France
Aphp - Hopital Pitie Salpetriere
Paris, France
🤝 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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