Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neu… (NCT07396922) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Poland120 participantsStarted 2026-12-30
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
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What they're measuring
1
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
Timeframe: Baseline to post-treatment (end of treatment, 3 weeks)
. Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.
✕. 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.
✕. 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.
✕. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.