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Clinical Trials/NCT04486209
NCT04486209
Completed
Early Phase 1

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

Medical University of Vienna1 site in 1 country15 target enrollmentDecember 27, 2017
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ConditionsMultiple Sclerosis

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Medical University of Vienna
Enrollment
15
Locations
1
Primary Endpoint
Modified Ashworth Scale
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
December 27, 2017
End Date
July 2, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ursula Hofstoetter

Senior researcher

Medical University of Vienna

Eligibility Criteria

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)

Study Sites (1)

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