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| Name | Class |
|---|---|
| P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Motor Function Measure Scale | Motor Function Measure (MFM) scale measurement before and after TMS sessions | 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. |
| Change from Baseline of the Revised Upper Limb Module | Revised Upper Limb Module (RULM) scale measurement before and after TMS sessions | 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. |
| Change from Baseline of the Hammersmith Functional Motor Scale - Expanded | Hammersmith Functional Motor Scale - Expanded (HFMSE) measurement before and after TMS sessions | 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. |
| Change from Baseline in the 6-Minute Walk Test | 6-Minute Walk Test (6MWT) measurement before and after TMS sessions | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vitaliy M Matyushenko | Contact | 380503640673 | csma.ua@gmail.com | |
| Andriy V Shatillo, MD, PhD | Contact | 380978111884 | shatil@ukr.net |
| Name | Affiliation | Role |
|---|---|---|
| Olena V Pisotska, MD, PhD | P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine | Principal Investigator |
| Andriy V Shatillo, MD, PhD | P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine | Recruiting | Kharkiv | Kharkiv Oblast | 61068 | Ukraine |
only IPD used in the results publication
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| lumbar puncture | Diagnostic Test | Cerebrospinal fluid sampling to measure SMN protein and neurofilament concentrations before and after the TMS intervention. |
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| Study Chair |
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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