Testing fatigue levels in patients with spinal muscular atrophy
Evaluation of the Reproducibility of a Fatigability Test Fitted to Patients With Spinal Muscular Atrophy
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT06562283
This study is testing new ways to measure fatigue in people with spinal muscular atrophy to help them manage their daily activities better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 4 sites (Saint-Etienne, France and 3 other locations) |
| Trial ID | NCT06562283 on ClinicalTrials.gov |
What this trial studies
This study evaluates a fatigability test specifically designed for patients with spinal muscular atrophy (SMA), a neuromuscular disease characterized by motor neuron degeneration. The research aims to adapt and validate a series of tests, including thumb and grip tests, as well as a quadriceps intermittent fatigue test, to assess muscle fatigue in SMA patients. By understanding fatigue levels, the study seeks to improve the management of daily activities for those affected by SMA, particularly in patients who have received treatment aimed at restoring SMN protein expression. The study includes patients aged 6 years and older who have a confirmed diagnosis of SMA.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 6 years and older with genetically confirmed spinal muscular atrophy.
Not a fit: Patients with other significant neurological diseases or joint deformities that interfere with testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better assessment and management of fatigue in patients with spinal muscular atrophy, enhancing their quality of life.
How similar studies have performed: While this approach is tailored for SMA, similar fatigue assessments have shown promise in other neuromuscular conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint-Etienne, France and 3 other locations
- Unités de Myologie et de Médecine du Sport — Saint-Etienne, France, France (RECRUITING)
- HCL - Hôpital Croix Rousse — Lyon, France (RECRUITING)
- HFME - Hospices Civils de Lyon — Lyon, France (RECRUITING)
- Aphp - Hopital Pitie Salpetriere — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Leonard FEASSON, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Leonard FEASSON, MD PhD
- Email: leonard.feasson@chu-saint-etienne.fr
- Phone: (0)4 77 12 03 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Amyotrophy, Infantile Spinal Muscular Atrophy, Juvenile Spinal Muscular Atrophy, Spinal Muscle Atrophy, Neuromuscular performance, Fatigue, Peripheral fatigue