NCT06977269 Safety and Tolerability of Low Motoneuron Stimulation Via Transcranial Magnetic Stimulation in Spinal Muscular Atrophy
| NCT ID | NCT06977269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charitable Foundation Children with Spinal Muscular Atrophy |
| Condition | Spinal Muscular Atrophy (SMA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-19 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There is a general physiological rule that any organ or system needs some minimal amount of activity to prevent its atrophy or degeneration. Although the relevance of that rule to exercises in neuromuscular patients and for SMA in particular is not definitely proven, clinical observations seem to support this assumption. Also there are several experimental studies which provide additional support for utility of exercise for SMA. However, making regular exercises may be very challenging with SMA not only due to physical limitations, but due to psychological either. While being considered as safe and well tolerated intervention, TMS is able to mimic effects of real physical exercises, at least at the level of low motoneuron, it also provides several advantages. For example, possibility to exercise non-collaborative infants, minimization of psychological motivation impact in adults and/or ability to involve very weak muscle groups.
Eligibility 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.
Contact & Investigator
Olena V Pisotska, MD, PhD
PRINCIPAL INVESTIGATOR
P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine
Frequently Asked Questions
Who can join the NCT06977269 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Spinal Muscular Atrophy (SMA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06977269 currently recruiting?
Yes, NCT06977269 is actively recruiting participants. Contact the research team at csma.ua@gmail.com for enrollment information.
Where is the NCT06977269 trial being conducted?
This trial is being conducted at Kharkiv, Ukraine.
Who is sponsoring the NCT06977269 clinical trial?
NCT06977269 is sponsored by Charitable Foundation Children with Spinal Muscular Atrophy. The principal investigator is Olena V Pisotska, MD, PhD at P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine. The trial plans to enroll 20 participants.