Spatial StimelMD for upper-limb recovery after stroke or traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CP-SSMD-01 is a multicenter, randomized, controlled comparison of the Spatial StimelMD (SSMD) device plus standard rehabilitation versus standard functional electrical stimulation (FES) plus standard care for adults with upper-limb neuromotor impairment after stroke or TBI. The study plans to enroll about 150 participants who will complete roughly 25 supervised treatment sessions over a 5–6 week period, with assessments at baseline, mid-treatment, post-treatment (primary endpoint), and a one-month follow-up. The primary outcome is change in upper-limb motor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), while secondary outcomes include movement metrics, EMG activation measures, functional independence, device usability, and adverse event monitoring. The trial tests whether spatially patterned stimulation delivered by SSMD provides greater motor recovery than standard FES.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18-80 years.
2. Clinically confirmed diagnosis of stroke or TBI within the past 12 months.
3. 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).
4. Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.
5. Subject is able to adhere to the study schedule and cognitively capable to perform the treatment.
6. Stable medical condition without ongoing acute complications that could interfere with participation.

Exclusion Criteria:

1. 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).
2. Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.
3. Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.
4. Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.
5. Presence of spinal shock or unresolved acute spinal cord dysfunction, characterized by complete loss of reflexes, flaccid paralysis, or autonomic instability.
6. Current participation in other clinical trials that could confound the study results.
7. 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.
8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

Where it's running

• Bnai Zion Medical Center
  Haifa, Israel Recruiting

Study contacts

• Principal investigator: Dr.Boris Chelibian — Bnai Zion Medical Center
• Study coordinator: Victoria Lashinker
• Email: victoria.lashinker@b-zion.org.il
• Phone: +972 525928545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.