AzTrials
AzTrials

Spinal AmyotrophyFANTASI-SMARTNCT06562283

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

A study testing Thumb test, Grip test and Quadriceps Intermittent Fatigue test (QIF test)) in people with Spinal Amyotrophy and Infantile Spinal Muscular Atrophy, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
Thumb test, Grip test and Quadriceps Intermittent Fatigue test (QIF test))
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
4 sitesFrance
Study dates
6 Dec 2024to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Leonard FEASSON, MD PhD contact

(0)4 77 12 03 83 ext. +33

leonard.feasson@chu-saint-etienne.fr

France4 sites, 4 recruiting

  • HCL - Hôpital Croix Rousse

    Lyon

    Shams RIBAULT, MD

    Shams RIBAULT, MD

    Recruiting

  • HFME - Hospices Civils de Lyon

    Lyon

    Carole VUILLEROT, MD PhD

    Carole VUILLEROT, MD PhD

    Recruiting

  • Aphp - Hopital Pitie Salpetriere

    Paris

    Tanya STOJKOVIC, MD

    Tanya STOJKOVIC, MD

    Recruiting

  • Unités de Myologie et de Médecine du Sport

    Saint-Etienne, France, 42055

    Léonard FEASSON, MD PhD, (0)4 77 12 03 83 ext. +33, leonard.feasson@chu-st-etienne.fr

    Diana RIMAUD, engineer, (0)477120467 ext. +33, diana.rimaud@chu-st-etienne.fr

    Recruiting

Other trials in France

About this study

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.

Being tested
Thumb test, Grip test, Quadriceps Intermittent Fatigue test (QIF test))
Keywords
Spinal Muscle Atrophy, Neuromuscular performance, Fatigue, Peripheral fatigue
Medical subject headings
Muscular Atrophy, Spinal, Spinal Muscular Atrophies of Childhood, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thumb testOther

    Thumb adduction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.

  • Grip testOther

    Muscle contraction gripping test, consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.

  • Quadriceps Intermittent Fatigue test (QIF test))Other

    Quadriceps muscle contraction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.

Study groups in NCT06562283
Study groupRoleWhat they receive
Ambulatory patients (SMA-AMB)ExperimentalThe patient is said to be "ambulant" if he or she is able to walk and perform a muscle contraction test with the quadriceps.
Receives: Other: Grip test; Other: Quadriceps Intermittent Fatigue test (QIF test))
Non-ambulatory patients capable of effective grasping (SMA-PRE)ExperimentalThe patient is said to be "non-ambulant", with the ability to grasp the hand.
Receives: Other: Thumb test; Other: Grip test
Non-ambulatory patients without grasping ability (SMA-POU)ExperimentalThe patient is said to be "non-ambulant", with the ability to contract the thumb, but without the ability to grasp the hand.
Receives: Other: Thumb test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day : 1

Secondary outcomes (8)

  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)

    Measured: Day : 1

  2. 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).

    Measured: Day : 1

  3. 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.

    Measured: Day : 1

  4. 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.

    Measured: Day : 1

  5. 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.

    Measured: Day : 1

  6. 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.

    Measured: Day : 1

  7. 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.

    Measured: Day : 1

  8. 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.

    Measured: Day : 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start6 Dec 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562283
Sponsor's protocol ID
23CH295
Other IDs
ANSM
Acronym
FANTASI-SMART
Status last verified
May 2026
First submitted
5 Aug 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Thumb test, Grip test and Quadriceps Intermittent Fatigue test (QIF test)) in people with Spinal Amyotrophy and Infantile Spinal Muscular Atrophy, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leonard FEASSON, MD PhD ((0)4 77 12 03 83 ext. +33, leonard.feasson@chu-saint-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of a fatigability test adapted to the motor level of the entire population of patients with spinal muscular atrophy. (time frame: Day : 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06562283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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