NCT06562283|Recruiting
Evaluation of the Reproducibility of a Fatigability Test Fitted to Patients With Spinal Muscular Atrophy
FANTASI-SMART
Loading search results
FANTASI-SMART
Sponsor study identifier
Secondary identifiers
OTHER · 2024-A00225-42
interventional
80
1 country
4
Study Start
December 6, 2024
Actual (reported)Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 living. The aim of this study is to adapt a fatigability test, widely validated in its original version in different populations (QIF test), but adapted in this protocol to the motor level and low abilities of certain SMA patients. Our objectives are to determine whether these assessments are feasible in SMA patients, reproducible, and relevant for monitoring this population, either routinely or for future clinical trials.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2024
Actual (reported)August 20, 2024
Actual (reported)December 6, 2024
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Feasibility of a fatigability test adapted to the motor level of the entire population of patients with spinal muscular atrophy.
Feasibility will be assessed by the patient's success in performing the fatigability test: i.e. performing at least 2 incremental steps (i.e. at least 10 contractions at 10% of their maximum strength, then 10 contractions at 20% of their maximum strength). Validation of the feasibility of the fatigability test will be obtained if at least 80% of patients are able to perform at least the first 2 stages.
Day : 1
Tolerance of fatigability test - Pain
Day : 1
Tolerance of fatigability test - RPE
Day : 1
The patient is said to be "ambulant" if he or she is able to walk and perform a muscle contraction test with the quadriceps.
The patient is said to be "non-ambulant", with the ability to grasp the hand.
Thumb adduction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.
Muscle contraction gripping test, consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.
Unités de Myologie et de Médecine du Sport
Saint-Etienne, France, 42055, France
Leonard FEASSON, MD PhD
Centre Hospitalier Universitaire de Saint Etienne
First Submitted
August 5, 2024
First Posted
August 20, 2024
Study Start
December 6, 2024
Actual (reported)Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Home Monitoring of Adult Patients With SMA: a Pilot Multicenter Validation Study
Tolerance of fatigability test - AEs
Day : 1
Reproducibility of the fatigability test
Day : 1
Reproducibility of the central and peripheral components of fatigue - VA
Day : 1
The patient is said to be "non-ambulant", with the ability to contract the thumb, but without the ability to grasp the hand.
Quadriceps muscle contraction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
HCL - Hôpital Croix Rousse
Lyon, France
HFME - Hospices Civils de Lyon
Lyon, France
Aphp - Hopital Pitie Salpetriere
Paris, France
Study Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 6, 2026
Record last verified: 2026-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: