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.
Adult men and women aged 18-80 years.
Clinically confirmed diagnosis of stroke, TBI, spinal cord injury, or peripheral nerve injury within the past 24 months.
Presence of moderate to severe neuromotor impairment in at least one limb, as evidenced by medical evaluation and a score <35 on the Fugl-Meyer Upper Extremity motor subscale (FMA-UE).
Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.
Presence of contraindications to electrical stimulation (ES), including implanted electronic medical devices (e.g., Cardiac demand pacemakers, Implantable pacemakers, Implantable cardioverter defibrillators, Implantable neurostimulators, Body-worn devices such as insulin pumps) or conditions that may be exacerbated by electrical stimulation (e.g., uncontrolled epilepsy).
Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.
Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.
Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.
Parallel
SSMD
DeviceSSMD 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)
DeviceFunctional electrical stimulation (FES) delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
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).
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.
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).
Change in EMG signal strength (threshold)
Change from baseline to post-treatment in electromyography (EMG) signal strength (threshold) during device-assisted assessment.
Change in Modified Ashworth Scale (MAS)
Change from baseline to post-treatment in spasticity as measured by the Modified Ashworth Scale (range 0-4; higher scores indicate greater spasticity and worse outcome). Time Frame: Baseline to end of treatment (Week 3).
Change in Stroke Impact Scale (SIS) score
Change from baseline to post-treatment in Stroke Impact Scale (SIS) score (range 0-100; higher scores indicate better function and less stroke impact). Time Frame: Baseline to end of treatment (Week 3).
Change in NIH Stroke Scale (NIHSS) score
Change from baseline to post-treatment in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42; higher scores indicate more severe neurologic deficit and worse outcome). Time Frame: Baseline to end of treatment (Week 3).
Change in Active Range of Motion (AROM) measured by goniometer
Change from baseline to post-treatment in active range of motion (AROM) (0-70 degrees), measured by goniometer.
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