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

October 18, 2023 updated by: Ursula Hofstoetter, Medical University of Vienna
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Ashworth Scale
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
10-m walk test
Time Frame: 24 hours
24 hours
2-min walk test
Time Frame: 24 hours
24 hours
Timed up an go test
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Collaborators

Neurological Center, Otto Wagner Hospital

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)

December 27, 2017

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version MS_tSCS_v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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