Spatial StimelMD for upper-limb recovery after stroke or traumatic brain injury
A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
This trial will test whether adding the Spatial StimelMD device to standard rehabilitation helps adults with upper-limb weakness after stroke or traumatic brain injury improve arm movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Motion Informatics LTD Industry-sponsored |
| Locations | 1 site (Haifa) |
| Trial ID | NCT07404761 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 years old with a confirmed stroke or TBI within the past 12 months, moderate to severe upper-limb impairment (FMA-UE <35), medically stable, cognitively able to consent, and able to attend supervised treatment sessions.
Not a fit: Patients with implanted electronic medical devices, uncontrolled seizures, significant medical instability, very mild impairment, or inability to attend frequent in-person sessions are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, SSMD could produce larger gains in arm strength and function than standard FES, helping people regain more independence in daily activities.
How similar studies have performed: Standard FES has demonstrated modest benefits for upper-limb recovery, but spatially patterned multichannel stimulation approaches like SSMD are relatively novel and have limited clinical outcome data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Haifa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.