Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Key facts
- Where
- Ustroń, PolandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07396922, who can take part
Where in Poland
- Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko UstrońUstroń, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Motion Informatics LTD
- Trial code
- NCT07396922
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
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.
Inclusion: 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; Subject is able to adhere to the study schedule and cognitively capable to perform the treatment; Stable medical condition without ongoing acute complications that could interfere with participation.
Exclusion: 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 acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device; Severe cognitive impairment that precludes the ability to provide informed consent or reliably adhere to the study protocol, as determined by cognitive screening and clinical judgment; Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients; Presence of spinal shock or unresolved acute spinal cord dysfunction, characterized by complete loss of reflexes, flaccid paralysis, or autonomic instability; Current participation in other clinical trials that could confound the study results; Women who are pregnant, nursing, or who plan to become pregnant while in the trial.