Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting
NCT ID: NCT02235090
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-10-31
2017-10-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Zero-strength of direct current stimulation
Sham transdermal direct current stimulation of cervical spinal cord
Direct current stimulation of cervical spinal cord
10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord
100 microamperes direct current stimulation
Transdermal direct current stimulation of cervical spinal cord
Direct current stimulation of cervical spinal cord
10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord
1 milliampere direct current stimulation
Transdermal direct current stimulation of cervical spinal cord
Direct current stimulation of cervical spinal cord
10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord
Interventions
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Direct current stimulation of cervical spinal cord
10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord
Eligibility Criteria
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Inclusion Criteria
* 5q SMA confirmed by molecular testing
Exclusion Criteria
* Hypersensitivity (pain or allergic reaction) to current stimulation
5 Years
ALL
Yes
Sponsors
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Charitable Foundation Children with Spinal Muscular Atrophy
OTHER
Responsible Party
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Principal Investigators
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Andriy V. Shatillo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"
Locations
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SI "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"
Kharkiv, , Ukraine
Countries
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Other Identifiers
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CSMA-INPN-1
Identifier Type: -
Identifier Source: org_study_id
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