NCT02235090

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

September 3, 2014

Last Update Submit

February 12, 2019

Conditions

Spinal Muscular AtrophyNeuromuscular Disorders

Keywords

Spinal muscular atrophyNeuromuscular disordersOutcome measuresVisit-free clinical trial design

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Short time fluctuations of Hammersmith Functional Motor Scale indexes

    Three times, three days consecutive measurement, every two months, assessed up to 6 months

Study Arms (3)

Zero-strength of direct current stimulation

SHAM COMPARATOR

Sham transdermal direct current stimulation of cervical spinal cord

Other: Direct current stimulation of cervical spinal cord

100 microamperes direct current stimulation

EXPERIMENTAL

Transdermal direct current stimulation of cervical spinal cord

Other: Direct current stimulation of cervical spinal cord

1 milliampere direct current stimulation

EXPERIMENTAL

Transdermal direct current stimulation of cervical spinal cord

Other: Direct current stimulation of cervical spinal cord

Interventions

Direct current stimulation of cervical spinal cordOTHER

10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord

1 milliampere direct current stimulation100 microamperes direct current stimulationZero-strength of direct current stimulation

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • q SMA confirmed by molecular testing

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SI "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"

Kharkiv, 61068, Ukraine

Location

MeSH Terms

Conditions

Muscular Atrophy, SpinalNeuromuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative Diseases

Study Officials

  • Andriy V. Shatillo, MD, PhD

    State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine"

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 9, 2014

Study Start

October 1, 2016

Primary Completion

September 30, 2017

Study Completion

October 30, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

UA(1)