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Trial was not started due to lack of funding and nobody received an intervention.
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Clinical trials organization in several neuromuscular disorders (NMD) has some specific issues. Nonambulant status and difficulties with transportation are among them. Moreover a lot of patients with NMD have so poor condition that even short transportation is able to worse it. Such situation forces researchers to limit a region of recruitment for clinical trials and to exclude from trials more severe subgroup of patients, which cause additional issues especially for rare diseases.
The purpose of this study is to prove hypothesis about possibility to reliably monitor patient condition remotely, without trial site visiting. Visit-free study design is potentially able to widen eligible patient population and to decrease patient dropout rate as well as burden of numerous assessments. Meanwhile assessment frequency could be increased enabling monitoring of short fluctuations in patients' condition.
Spinal muscular atrophy (SMA) is a rare neuromuscular condition to which all mentioned above issues are completely applicable. Direct current stimulation (DCS) of neural structures is well studied and safe intervention, however, its effects on SMA patients' strength and durability has not been reported for today. The investigators suppose that investigation of DCS action in SMA patient population is an adequate model for visit-free design feasibility, reliability and sensitivity evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero-strength of direct current stimulation | Sham Comparator | Sham transdermal direct current stimulation of cervical spinal cord |
|
| 100 microamperes direct current stimulation | Experimental | Transdermal direct current stimulation of cervical spinal cord |
|
| 1 milliampere direct current stimulation | Experimental | Transdermal direct current stimulation of cervical spinal cord |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct current stimulation of cervical spinal cord | Other | 10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord |
| Measure | Description | Time Frame |
|---|---|---|
| Strength Changes from baseline measured by handheld myometry after spinal cord direct current stimulation of different intensity | Before and 0, 15, 30 minutes after spinal cord direct current stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Short time fluctuations of Hammersmith Functional Motor Scale indexes | Three times, three days consecutive measurement, every two months, assessed up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andriy V. Shatillo, MD, PhD | State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SI "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine" | Kharkiv | 61068 | Ukraine |
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| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
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