Transcutaneous Spinal Cord Stimulation (tSCS) in Therapy to Analyze Long-Term Effects on Spasticity and Gait Impairment in Multiple Sclerosis
Not Applicable
Recruiting
- Conditions
- Secondary Progressive Multiple Sclerosis (SPMS)Primary Progressive Multiple Sclerosis (PPMS)Gait impairmentSpasticityG35.3G35.2
- Registration Number
- DRKS00032742
- Lead Sponsor
- Charité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
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
(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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (a) Change in spasticity measured by clinical assessment using modified Ashworth Scale (MAS).<br>(b) Change in gait speed expressed by a change in distance traveled in the 2-minute gait test.
- Secondary Outcome Measures
Name Time Method (c) Change in MS-specific clinical functional disability (EDSS Score),<br>(d) Change in maximum unaided walking distance,<br>(e) Change in individual gait parameters, such as step length, gait cycle, indicating improved/deteriorated gait function,<br>(f) Change in timed-up-and-go test (time reduced/increased),<br>(g) Altered postural stability,<br>(h) Correlation of spasticity score in clinical assessment (MAS, Tardieu scale) with electrophysiological parameters (tSCS double pulses, posterior root muscle reflexes)