Transcutaneous spinal cord stimulation (tSCS) for the treatment of spasticity and gait disorders in multiple sclerosis

Not Applicable

• Conditions: G35; G35.2; G35.3; Multiple sclerosis

• Registration Number: DRKS00023357
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

confirmed diagnosis of multiple sclerosis with a moderate to severe spasticity (Modified Ashworth Scale scores of 2-4)

Exclusion Criteria

1) Active lumbosacral nerve root compression
2) status after operation of the vertebral bodies in the stimulation area, as well as metal implants in the stimulation area (distance at least 5 cm from the edge of the adhesive electrode)
3) pacemaker implant
4) MS flare-up event in the past 6 months
5) Current pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of spasticity with transcutaneous spinal cord stimulation (clinical assesment with Modified Ashworth Scale)

Secondary Outcome Measures

Name	Time	Method
a) Improvement of MS-specific clinical functional impairment (Expanded Disability Status Scale)<br><br>b) Extension of the maximum walking distance without aids.<br><br>c) Improvement of the walking speed in the 10-meter walking test.<br><br>d) Correlation of the spasticity assessment in the clinical assessment (Modified Ashworth Scale) with electrophysiological parameters (Hoffmann reflex and tSCS double pulses)