This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.
This is a clinical investigation of the Spatial StimeMD (SSMD) medical device in participants diagnosed with multiple sclerosis (MS). The purpose of the study is to evaluate the safety and performance of the device in a controlled clinical setting. Participants will be followed according to the study schedule and will undergo assessments of MS symptoms, physical function, and other relevant clinical outcomes. Safety will be assessed through monitoring of adverse events and other safety parameters throughout the study. Study data will be collected and reviewed according to the protocol, including verification against source documentation as required.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
SSMD device-based therapy delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Functional electrical stimulation (FES) delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń
Ustroń, Poland
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
Change from baseline in Fugl-Meyer Assessment Upper Extremity (Motor Function Subscale) The Fugl-Meyer Assessment Upper Extremity motor score is a clinician-rated measure of upper limb motor impairment following neurological injury. Scores range from 0 to 66, with higher scores representing less impairment and better motor function. Time Frame: Baseline to post-treatment (3 weeks).
Time frame: Baseline to post-treatment (end of treatment, 3 weeks)
change in Movement range and movement quality (SSMD assessment mode)
Change from baseline to post-treatment in movement range and movement quality as assessed using the SSMD system assessment mode.
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in Functional Independence Measure (FIM) score
Change from baseline to post-treatment in activities of daily living as measured by the Functional Independence Measure (FIM) total score (range 18-126, higher scores indicate greater independence and better functional outcome). Time Frame: Baseline to end of treatment (Week 3).
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in EMG signal strength (threshold)
Change from baseline to post-treatment in electromyography (EMG) signal strength (threshold) during device-assisted assessment.
Time frame: Baseline to post-treatment (end of treatment, Week 3)
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