G35 G35.2 G35.3
Conditions
Interventions
Group 1: Measurement No.1: Sham
Measurement No.2: 50 Hz
Group 2: Measurement No.1: 50 Hz
Measurement No.2: Sham
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
20 Years to 85 Years
Inclusion criteria
Inclusion criteria: confirmed diagnosis of multiple sclerosis with a moderate to severe spasticity (Modified Ashworth Scale scores of 2-4)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of spasticity with transcutaneous spinal cord stimulation (clinical assesment with Modified Ashworth Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Extension of the walking distance in the 2-minute gait test. c) Improvement of the walking speed in the 10-meter walking test and timed up-and-go test. d) Correlation of the spasticity assessment in the clinical assessment (Modified Ashworth Scale) with electrophysiological parameters (tSCS reflexes) d) Improvement of kinematic data of the lower extremity (e.g. range of motion of the ankle) e) Investigation of side-specific and joint-specific spasticity changes f) Examination of tolerance (pain questionnaire) | — |
Countries
Germany
Contacts
Public ContactNikolaus Wenger
Charité – Universitätsmedizin Berlin
Outcome results
None listed