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.