Using magnetic stimulation to improve muscle function in spinal muscular atrophy
Safety and Tolerability of Low Motoneuron Stimulation Via Transcranial Magnetic Stimulation in Spinal Muscular Atrophy
NA · Charitable Foundation Children with Spinal Muscular Atrophy · NCT06977269
This study is testing whether a type of brain stimulation can help improve muscle function in people with spinal muscular atrophy without them having to do any physical exercise.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Charitable Foundation Children with Spinal Muscular Atrophy (other) |
| Locations | 1 site (Kharkiv, Kharkivs’ka Oblast’) |
| Trial ID | NCT06977269 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of low motoneuron stimulation using transcranial magnetic stimulation (TMS) in patients with spinal muscular atrophy (SMA). The approach aims to mimic the effects of physical exercise, which can be challenging for SMA patients due to physical and psychological limitations. By applying high-frequency repetitive TMS, the study seeks to engage weak muscle groups and provide therapeutic benefits without requiring active participation from the patients. The study includes specific eligibility criteria to ensure that participants can safely engage with the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with 5q-autosomal recessive SMA who can perform minimal hand functions.
Not a fit: Patients with severe joint contractures or significant cognitive and behavioral issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance muscle function and overall quality of life for patients with spinal muscular atrophy.
How similar studies have performed: While the use of TMS in this context is innovative, previous studies have shown promise in using similar approaches for neuromuscular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has a diagnosis of 5q-autosomal recessive SMA confirmed by DNA test. * Informed consent. * A minimum score of 1 for Entry Item "A" of the Revised Upper Limb Module (RULM) scale for SMA: "Can use hands to hold pencil or pick up a coin/token or drive a powered chair, use phone key pad" Exclusion Criteria: * Subject has severe joint contractures that would affect ability to perform study measures, determined by the study physician. * Subject has a deconditioned respiratory system, per the discretion of the physician investigator. * Subject has behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator.
Where this trial is running
Kharkiv, Kharkivs’ka Oblast’
- P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine — Kharkiv, Kharkivs’ka Oblast’, Ukraine (RECRUITING)
Study contacts
- Principal investigator: Olena V Pisotska, MD, PhD — P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine
- Study coordinator: Vitaliy M Matyushenko
- Email: csma.ua@gmail.com
- Phone: 380503640673
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 Muscular Atrophy, spinal muscular atrophy, Survival Motor Neuron protein, Neurofilament, transcranial magnetic stimulation