Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments

Starting soon · Not applicable

Conditions studied: Stroke, TBI, Spinal Cord Injury, Peripheral Nerve Damage

In brief

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.

Key facts

Study ID

NCT07396922

Run by

Motion Informatics LTD

People needed

120

Starts

2026-12-30

Expected to finish

2027-01-30

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń — Ustroń, Poland

Full record on ClinicalTrials.gov

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