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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Early Phase 1
Locations
Austria
Study Type
Interventional
Intervention
transcutaneous spinal cord stimulation
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring neuromodulation, spinal cord stimulation, walking function, spasticity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Outcomes

Primary Outcome Measures

Modified Ashworth Scale

Secondary Outcome Measures

10-m walk test
2-min walk test
Timed up an go test

Full Information

First Posted
July 17, 2020
Last Updated
October 18, 2023
Sponsor
Medical University of Vienna
Collaborators
Neurological Center, Otto Wagner Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04486209
Brief Title
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis
Acronym
noSpasMS
Official Title
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Neurological Center, Otto Wagner Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neuromodulation, spinal cord stimulation, walking function, spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
transcutaneous spinal cord stimulation
Intervention Description
electrical stimulation of the lumbosacral spinal cord through surface electrodes
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
10-m walk test
Time Frame
24 hours
Title
2-min walk test
Time Frame
24 hours
Title
Timed up an go test
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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