Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting

February 12, 2019 updated by: Charitable Foundation Children with Spinal Muscular Atrophy

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kharkiv, Ukraine, 61068
        • SI "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before and 0, 15, 30 minutes after spinal cord direct current stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Three times, three days consecutive measurement, every two months, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charitable Foundation Children with Spinal Muscular Atrophy

Investigators

  • Principal Investigator: Andriy V. Shatillo, MD, PhD, State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMA-INPN-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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