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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02235090 |
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Date of registration:
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03/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting
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Scientific title:
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Assessment of Feasibility and Statistical Reliability of Functional Outcomes Measurement in Neuromuscular Patients Without Trial Site Visiting by Standard Functional Scales and by Special Autonomic Device in Double-blind, Placebo Controlled Study of Cervical Spinal Cord Transdermal Direct Current Stimulation in Patients With Spinal Muscular Atrophy |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02235090 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Ukraine
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Contacts
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Name:
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Andriy V. Shatillo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine" |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- 5q SMA confirmed by molecular testing
Exclusion Criteria:
- Need for ventilation
- Hypersensitivity (pain or allergic reaction) to current stimulation
Age minimum:
5 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuromuscular Disorders
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Spinal Muscular Atrophy
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Intervention(s)
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Other: Direct current stimulation of cervical spinal cord
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Primary Outcome(s)
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Strength Changes from baseline measured by handheld myometry after spinal cord direct current stimulation of different intensity
[Time Frame: Before and 0, 15, 30 minutes after spinal cord direct current stimulation]
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Secondary Outcome(s)
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Short time fluctuations of Hammersmith Functional Motor Scale indexes
[Time Frame: Three times, three days consecutive measurement, every two months, assessed up to 6 months]
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Secondary ID(s)
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CSMA-INPN-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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