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RECRUITING
NCT06977269
NA

Safety and Tolerability of Low Motoneuron Stimulation Via Transcranial Magnetic Stimulation in Spinal Muscular Atrophy

Sponsor: Charitable Foundation Children with Spinal Muscular Atrophy

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-19

Completion Date

2026-01

Last Updated

2025-06-18

Healthy Volunteers

No

Interventions

DEVICE

High-frequency repetitive transcranial magnetic stimulation

High-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex (M1) of the limbs, delivered at a frequency above 5 Hz and an intensity of 90-100% of the resting motor threshold, across 10 sessions with up to 2400 stimuli per session, is a standard intervention used in various neurological disorders. However, its effects have not been studied in patients with spinal muscular atrophy (SMA).

DIAGNOSTIC_TEST

lumbar puncture

Cerebrospinal fluid sampling to measure SMN protein and neurofilament concentrations before and after the TMS intervention.

Locations (1)

P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine

Kharkiv, Kharkivs’ka Oblast’, Ukraine