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

Multiple Sclerosis Clinical Trial

— noSpasMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486209
• Other study ID #: Version MS_tSCS_v1
• Status: Completed
• Phase: Early Phase 1
• Start date: December 27, 2017
• Est. completion date: July 2, 2020

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis

Intervention

Device:
• transcutaneous spinal cord stimulation
electrical stimulation of the lumbosacral spinal cord through surface electrodes

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Neurological Center, Otto Wagner Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale		24 hours
Secondary	10-m walk test		24 hours
Secondary	2-min walk test		24 hours
Secondary	Timed up an go test		24 hours