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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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ClinicalTrials.gov Identifier: NCT02235090
Recruitment Status : Withdrawn (Trial was not started due to lack of funding and nobody received an intervention.)
First Posted : September 9, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Charitable Foundation Children with Spinal Muscular Atrophy

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spinal Muscular Atrophy Neuromuscular Disorders Other: Direct current stimulation of cervical spinal cord Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : October 30, 2017


Arm Intervention/treatment
Sham Comparator: Zero-strength of direct current stimulation
Sham transdermal direct current stimulation of cervical spinal cord
Other: 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

Experimental: 100 microamperes direct current stimulation
Transdermal direct current stimulation of cervical spinal cord
Other: 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

Experimental: 1 milliampere direct current stimulation
Transdermal direct current stimulation of cervical spinal cord
Other: 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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • 5q SMA confirmed by molecular testing

Exclusion Criteria:

  • Need for ventilation
  • Hypersensitivity (pain or allergic reaction) to current stimulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235090


Locations
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Ukraine
SI "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"
Kharkiv, Ukraine, 61068
Sponsors and Collaborators
Charitable Foundation Children with Spinal Muscular Atrophy
Investigators
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Principal Investigator: Andriy V. Shatillo, MD, PhD State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"

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Responsible Party: Charitable Foundation Children with Spinal Muscular Atrophy
ClinicalTrials.gov Identifier: NCT02235090     History of Changes
Other Study ID Numbers: CSMA-INPN-1
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Charitable Foundation Children with Spinal Muscular Atrophy:
Spinal muscular atrophy
Neuromuscular disorders
Outcome measures
Visit-free clinical trial design
Additional relevant MeSH terms:
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Neuromuscular Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Muscular Atrophy
Muscular Atrophy, Spinal
Atrophy
Neurologic Manifestations
Signs and Symptoms