NCT07396922Not yet recruiting
Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 30 Dec 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Motion Informatics LTD
- Diseases
- Stroke
- NCT number
- NCT07396922
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 30 Dec 2026 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń Coordinator of this site? Confirm its status | Ustroń | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.