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

NCT07404761 | Recruiting DMC

• 1 other identifier: CP-SSMD-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Upper-limb Motor Impairment; Hemiparesis; Spinal Cord Injury; Traumatic Brain Injury

Keywords

randomized; ssmd; neuromotor rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

  Change from baseline to end of treatment in the Fugl-Meyer Assessment Upper Extremity (FMA-UE) motor function score (range 0-66), with higher scores indicating better motor function (better outcome).

  Baseline to end of treatment (post-treatment; approximately 5-6 weeks)

Secondary Outcomes (3)

• Movement Quality (SSMD Assessment Mode)

  Baseline to end of treatment (approximately 5-6 weeks)

• EMG Signal Strength (Threshold)

  Baseline to end of treatment (approximately 5-6 weeks)

• Functional Independence Measure (FIM)

  Baseline to end of treatment (approximately 5-6 weeks)

Other Outcomes (1)

• Modified Ashworth Scale (MAS)

  Baseline to end of treatment (approximately 5-6 weeks)

Study Arms (2)

SSMD Therapy + Standard Care

EXPERIMENTAL

Participants receive Spatial StimelMD (SSMD) therapy in addition to standard rehabilitation care. Treatment includes approximately 25 supervised sessions delivered over 5-6 weeks.

Device: Spatial StimelMD (SSMD)

Standard FES + Standard Care

ACTIVE COMPARATOR

Participants receive standard functional electrical stimulation (FES) in addition to standard rehabilitation care. Treatment includes approximately 25 supervised sessions delivered over 5-6 weeks.

Device: Functional Electrical Stimulation (FES)

Interventions

Spatial StimelMD (SSMD) DEVICE

Spatial StimelMD (SSMD) is a device-based neuromotor rehabilitation intervention used for upper-limb therapy. Participants receive SSMD therapy in supervised sessions as part of a structured rehabilitation program over approximately 5-6 weeks (about 25 sessions).

SSMD Therapy + Standard Care

Functional Electrical Stimulation (FES) DEVICE

Functional electrical stimulation (FES) is a standard device-based intervention used in rehabilitation to stimulate muscle activation for upper-limb therapy. Participants receive FES in supervised sessions as part of standard rehabilitation care over approximately 5-6 weeks (about 25 sessions).

Standard FES + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Motion Informatics LTD: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3339419, Israel

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis; Spinal Cord Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Craniocerebral Trauma

Study Officials

• Dr.Boris Chelibian

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Lashinker

CONTACT

+972 525928545; victoria.lashinker@b-zion.org.il

Julia Sterlin

CONTACT

+972 52-897-6129; julia.sterlin@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This is an open-label study with no masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized into two parallel groups to receive either SSMD therapy plus standard rehabilitation care or standard functional electrical stimulation (FES) plus standard care over approximately 5-6 weeks.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 11, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)