Secondary Progressive Multiple Sclerosis (SPMS) Primary Progressive Multiple Sclerosis (PPMS) Gait impairment Spasticity G35.3 G35.2
Conditions
Interventions
Group 1: To investigate the feasibility and efficacy of tSCS therapy for MS, an interventional, exploratory pilot study in the form of a prospective case series will be conducted, without a control gr
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
20 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Confirmed diagnosis of secondary or primary progressive multiple sclerosis; (2) Symptoms: moderate to severe spasticity, gait symptoms; (3) Tolerability of tSCS confirmed in previous study (immediate effect)
Exclusion criteria
Exclusion criteria: (1) Active lumbosacral nerve root compression; (2) Time after surgery of the vertebral bodies in the stimulation area, as well as metal implants in the stimulation area (distance min. 5 cm from the edge of the adhesive electrode); (3) Pacemaker implants; (4) MS relapse event in the past 6 months; (5) Current pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (a) Change in spasticity measured by clinical assessment using "modified Ashworth Scale (MAS)". (b) Change in gait speed expressed by a change in "distance traveled in the 2-minute gait test". | — |
Secondary
| Measure | Time frame |
|---|---|
| (c) Change in individual gait parameters for improved/deteriorated gait function, (d) Change in timed-up-and-go test (time reduced/increased), (e) Altered postural stability, (f) Correlation of spasticity score in clinical assessment (MAS, Tardieu scale) with electrophysiological parameters (posterior root muscle reflexes) | — |
Countries
Germany
Contacts
Public ContactNikolaus Wenger
Charité Universitätsmedizin Berlin
Outcome results
None listed