NCT04486209

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1 multiple-sclerosis

Timeline
Completed

Started Dec 2017

Typical duration for early_phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 27, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

July 17, 2020

Last Update Submit

October 18, 2023

Conditions

Multiple Sclerosis

Keywords

neuromodulationspinal cord stimulationwalking functionspasticity

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth Scale

    24 hours

Secondary Outcomes (3)

  • 10-m walk test

    24 hours

  • 2-min walk test

    24 hours

  • Timed up an go test

    24 hours

Interventions

transcutaneous spinal cord stimulationDEVICE

electrical stimulation of the lumbosacral spinal cord through surface electrodes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Multiple SclerosisMuscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 24, 2020

Study Start

December 27, 2017

Primary Completion

July 2, 2020

Study Completion

July 2, 2020

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)