An interventional study of Thumb test and Grip test in Spinal Amyotrophy, Infantile Spinal Muscular Atrophy and Juvenile Spinal Muscular Atrophy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 4 sites in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
Among 11 studies in Spinal Muscular Atrophies of Childhood with a site in France — 3 open to participants now, 5 under way, 2 of them phase 3. Spinal Muscular Atrophies of Childhood · France.
Among the 11 studies in Spinal Muscular Atrophies of Childhood with a site in France, this one is the 6th largest by planned enrollment, is one of 2 that started in 2024, is one of 6 with no phase, and was the 10th registered.
61 studies on the registry are indexed under Spinal Muscular Atrophies of Childhood; 18 are open to participants now.
Browse Spinal Muscular Atrophies of Childhood studies →3 of the 11 studies in Spinal Muscular Atrophies of Childhood with a site in France are open now. Recruiting first, the newest first:
Scholar Rock, Inc. · Sites in France, United States, Belgium and 4 more countries
Ages up to 2
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages up to 12 mo
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 12 Spinal Muscular Atrophies of Childhood studies recruiting now, 5 (42%) set no upper age limit and 7 (58%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 6 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 80 is above the median of 15 across 41 interventional studies indexed under Spinal Muscular Atrophies of Childhood.
Median enrollment 80 across the 11 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 11 have an industry lead sponsor. The 6 most frequent:
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Centre Hospitalier Universitaire de Saint Etienne has 1 study filed under Spinal Muscular Atrophies of Childhood — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Spinal Muscular Atrophies of Childhood with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
61 studies on the registry are indexed under Spinal Muscular Atrophies of Childhood; 18 are open to participants now.
This study's planned enrollment of 80 is above the median of 15 across 41 interventional studies indexed under Spinal Muscular Atrophies of Childhood.
Browse Spinal Muscular Atrophies of Childhood studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Compared within Spinal Muscular Atrophies of Childhood, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Muscular Atrophy, Spinal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient is said to be "ambulant" if he or she is able to walk and perform a muscle contraction test with the quadriceps.
Other: Grip test · Other: Quadriceps Intermittent Fatigue test (QIF test))
The patient is said to be "non-ambulant", with the ability to grasp the hand.
Other: Thumb test · Other: Grip test
The patient is said to be "non-ambulant", with the ability to contract the thumb, but without the ability to grasp the hand.
Other: Thumb test
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.
Quadriceps muscle contraction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.
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.
Time frame: Day : 1
Tolerance of fatigability test - Pain
The tolerance of the fatigability test will be measured by a visual analogue pain scale for adults and the FPS-R face scale for children, as recommended by the French National Authority for Health (HAS)
Time frame: Day : 1
Tolerance of fatigability test - RPE
The tolerance of the fatigability test will be measured by perception of exertion (RPE) using the Borg scale (from 0 - rest to 10 - Maximal perceived effort).
Time frame: Day : 1
Tolerance of fatigability test - AEs
The tolerance of the fatigability test will be measured by the recording of adverse events (AEs) such as pain, discomfort, cramp; before, at each stage and at the end of the test. Tolerability of the fatigability test will be achieved if at least 90% of patients are able to carry out the test without having to stop it early because of the occurrence of AEs.
Time frame: Day : 1
Reproducibility of the fatigability test
The reproducibility of the fatigability test will be assessed by measuring and comparing the maximum voluntary force (MVC, en Nm) and the loss of force, assessed by the same assessor.
Time frame: Day : 1
Reproducibility of the central and peripheral components of fatigue - VA
The reproducibility of the central and peripheral components of fatigue will be assessed by the difference in the level of voluntary activation (% Voluntary Activation, VA) assessed by the same assessor.
Time frame: Day : 1
Reproducibility of the central and peripheral components of fatigue - magnetic jerk
The reproducibility of the central and peripheral parts of the fatigue will be evaluated by the difference in the amplitude of the magnetic jerk at rest (% jerk) of the muscles investigated, evaluated by the same evaluator.
Time frame: Day : 1
Perceived fatigue - FACIT-F
Perceived fatigue will be measured by the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy) for adult patients. The FACIT-F is the instrument most frequently used to assess fatigue in the various chronic pathologies associated with chronic fatigue. It consists of a short questionnaire with 13 questions, which the patient answers on a scale from 0 to 4. The scores are added together, inverting the scale for negative sentences, to give a score out of 52 points. The lower the score, the greater the fatigue.
Time frame: Day : 1
Perceived fatigue - PedsQL 4.0
Perceived fatigue will be measured by the PedsQL 4.0 fatigue questionnaire in the youngest patients (questionnaire for 6-8 year olds, 8-12 year olds, 12-17 year olds). Scores are transformed on a scale from 0 to 100, with higher scores indicating better functioning, ie lower fatigue.
Time frame: Day : 1
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Oct 2026, 22 months after the start.
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