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Clinical Trials/NCT04486209
NCT04486209CompletedEarly Phase 1

Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis

Medical University of Vienna2 sites in 1 country15 target enrollmentStarted: December 27, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Modified Ashworth Scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising intervention methods to improve motor function in individuals with severe spinal cord injury. In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve spasticity and residual motor control in the same subject population. The present study explores whether single sessions of noninvasive SCS would improve walking performance and ameliorate spasticity in individuals with multiple sclerosis.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive MS
  • •lower-limb spasticity

Exclusion Criteria

  • •acute relapse of MS
  • •other neuromuscular diseases
  • •active and passive implants at vertebral level T9 or caudally
  • •dermatological issues at stimulation site
  • •pregnancy

Outcomes

Primary Outcomes

Modified Ashworth Scale

Time Frame: 24 hours

Secondary Outcomes

  • Timed up an go test(24 hours)
  • 2-min walk test(24 hours)
  • 10-m walk test(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ursula Hofstoetter

Senior researcher

Medical University of Vienna

Study Sites (2)

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