Spinal Muscular Atrophy (SMA) Clinical Trials

Find Spinal Muscular Atrophy (SMA) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ukraine
P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine
RECRUITING
Kharkiv
Contact Information
Primary
Vitaliy M Matyushenko
csma.ua@gmail.com
380503640673
Backup
Andriy V Shatillo, MD, PhD
shatil@ukr.net
380978111884
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2026-01
Participants
Target number of participants: 20
Treatments
Experimental: TMS arm
Stimulation (HF-rTMS) of the primary motor cortex, M1 area of the limbs, at a frequency above 5 Hz and an intensity of 90-100% of the resting motor threshold (RMT), over 10 sessions, up to 2400 stimuli per session.
Sponsors
Leads: Charitable Foundation Children with Spinal Muscular Atrophy
Collaborators: P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine

This content was sourced from clinicaltrials.gov