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NCT Number: NCT06977269

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

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.

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Key information

Conditions

Spinal Muscular Atrophy (SMA) Central Nervous System Diseases Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kharkiv, Kharkiv Oblast, 61068, Ukraine

Location status: Recruiting

Location contact

Olena Pisotska Medical Director, MD, PhD

CONTACT

[email protected]

380577384194

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-frequency repetitive transcranial magnetic stimulation

Device

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).

Other names: HF-rTMS

Lumbar puncture

Diagnostic Test

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

Primary outcomes

  1. Change from Baseline in the Motor Function Measure Scale

    Time frame: The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.

    Motor Function Measure (MFM) scale measurement before and after TMS sessions

  2. Change from Baseline of the Revised Upper Limb Module

    Time frame: The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.

    Revised Upper Limb Module (RULM) scale measurement before and after TMS sessions

  3. Change from Baseline of the Hammersmith Functional Motor Scale - Expanded

    Time frame: The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.

    Hammersmith Functional Motor Scale - Expanded (HFMSE) measurement before and after TMS sessions

  4. Change from Baseline in the 6-Minute Walk Test

    Time frame: The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.

    6-Minute Walk Test (6MWT) measurement before and after TMS sessions

Study contacts

Contact information is provided by the study sponsor or research team.

Andriy V Shatillo, MD, PhD

CONTACT

[email protected]

380978111884

Vitaliy M Matyushenko

CONTACT

[email protected]

380503640673

Sponsors and collaborators

Lead sponsor

Charitable Foundation Children with Spinal Muscular Atrophy

Other

Collaborators

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

Registry information

Acronym: STIM-SMA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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