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

Recruiting now · Not applicable

Conditions studied: Stroke, Upper-limb Motor Impairment, Hemiparesis, Spinal Cord Injury, Traumatic Brain Injury

In brief

This is a multicenter, randomized, controlled clinical study evaluating the safety and effectiveness of the Spatial StimelMD (SSMD) device for upper-limb neuromotor rehabilitation in adults with impairment following stroke or traumatic brain injury (TBI). Participants will be randomized to receive either SSMD therapy plus standard rehabilitation care or standard functional electrical stimulation (FES) plus standard care. Subjects will complete approximately 25 supervised treatment sessions over 5-6 weeks, with assessments at baseline, mid-treatment, post-treatment (primary endpoint), and a 1-month follow-up. The primary effectiveness endpoint is improvement in upper-limb motor function measured by the Fugl-Meyer Upper Extremity (FMA-UE) assessment. Secondary outcomes include movement metrics, EMG signal strength, functional independence, usability measures, and adverse event monitoring. The study plans to enroll approximately 150 subjects to achieve 126 completers, across 2-6 clinical sites.

Key facts

Study ID: NCT07404761
Run by: Motion Informatics LTD
People needed: 150
Starts: 2025-12-22
Expected to finish: 2026-12-30
Last updated by the study team: 2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged 18-80 years.
Clinically confirmed diagnosis of stroke or TBI within the past 12 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., pacemakers, 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

Bnai Zion Medical Center — Haifa, Israel (enrolling)

Full record on ClinicalTrials.gov

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