StrokeNCT07404761
Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
A study testing Spatial StimelMD (SSMD) and Functional Electrical Stimulation (FES) in people with Stroke and Upper-limb Motor Impairment, run by Motion Informatics LTD at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper-limb Motor Impairment, Hemiparesis
- What is being tested?
- Spatial StimelMD (SSMD) and Functional Electrical Stimulation (FES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 3339419
Victoria Lashinker, +972 525928545, victoria.lashinker@b-zion.org.il
Julia Sterlin, +972 52-897-6129, Julia.Sterlin@b-zion.org.il
About this study
Official title: A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
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.
Read more
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.
Read the detailed description
CP-SSMD-01 is a multicenter, randomized, controlled clinical study designed to evaluate 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). The study compares SSMD therapy plus standard rehabilitation care to standard functional electrical stimulation (FES) plus standard care. Participants will complete approximately 25 supervised treatment sessions over a 5-6 week period.
Subjects will undergo evaluations at baseline, mid-treatment, post-treatment (the primary endpoint), and a follow-up visit approximately one month after completing therapy. The primary outcome measure is improvement in upper-limb motor function assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE). Secondary outcomes include additional measures of motor performance and movement quality, EMG-based muscle activation metrics, functional independence outcomes, usability assessments, and safety monitoring through adverse event reporting.
The study aims to enroll approximately 150 participants, with an expected 126 completing the full protocol, across 2-6 clinical sites. This trial is intended to generate clinical evidence on whether SSMD therapy can support meaningful upper-limb motor recovery compared with a standard stimulation-based rehabilitation approach in individuals affected by stroke or TBI.
- Conditions
- Stroke, Upper-limb Motor Impairment, Hemiparesis, Spinal Cord Injury, Traumatic Brain Injury
- Being tested
- Spatial StimelMD (SSMD), Functional Electrical Stimulation (FES)
- Keywords
- randomized, ssmd, neuromotor rehabilitation
- Medical subject headings
- Stroke, Paresis, Spinal Cord Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Functional Electrical Stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to end of treatment (post-treatment; approximately 5-6 weeks)
Secondary outcomes (3)
Movement Quality (SSMD Assessment Mode)
Change in upper-limb movement quality measured using SSMD assessment mode metrics.
Measured: Baseline to end of treatment (approximately 5-6 weeks)
EMG Signal Strength (Threshold)
Change in EMG signal strength (threshold) measured during study assessments.
Measured: Baseline to end of treatment (approximately 5-6 weeks)
Functional Independence Measure (FIM)
Change from baseline to end of treatment in the Functional Independence Measure (FIM) total score (range 18-126), with higher scores indicating greater functional independence (better outcome).
Measured: Baseline to end of treatment (approximately 5-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start22 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motion Informatics LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr.Boris Chelibian, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404761
- Sponsor's protocol ID
- CP-SSMD-01
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
- ClinicalTrials.gov ID
- NCT07404761
- Acronym / sponsor ID
- CP-SSMD-01
- Conditions
- Stroke, Upper-limb Motor Impairment, Hemiparesis, Spinal Cord Injury, Traumatic Brain Injury
- Keywords
- randomized, ssmd, neuromotor rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Motion Informatics LTDIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CP-SSMD-01 is a multicenter, randomized, controlled clinical study designed to evaluate 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). The study compares SSMD therapy plus standard rehabilitation care to standard functional electrical stimulation (FES) plus standard care. Participants will complete approximately 25 supervised treatment sessions over a 5-6 week period.
Subjects will undergo evaluations at baseline, mid-treatment, post-treatment (the primary endpoint), and a follow-up visit approximately one month after completing therapy. The primary outcome measure is improvement in upper-limb motor function assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE). Secondary outcomes include additional measures of motor performance and movement quality, EMG-based muscle activation metrics, functional independence outcomes, usability assessments, and safety monitoring through adverse event reporting.
The study aims to enroll approximately 150 participants, with an expected 126 completing the full protocol, across 2-6 clinical sites. This trial is intended to generate clinical evidence on whether SSMD therapy can support meaningful upper-limb motor recovery compared with a standard stimulation-based rehabilitation approach in individuals affected by stroke or TBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SSMD Therapy + Standard Care | Experimental | Device: Spatial StimelMD (SSMD)Participants receive Spatial StimelMD (SSMD) therapy in addition to standard rehabilitation care. Treatment includes approximately 25 supervised sessions delivered over 5-6 weeks. |
| Standard FES + Standard Care | Active comparator | Device: Functional Electrical Stimulation (FES)Participants receive standard functional electrical stimulation (FES) in addition to standard rehabilitation care. Treatment includes approximately 25 supervised sessions delivered over 5-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatial StimelMD (SSMD)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). | Device | SSMD Therapy + Standard Care |
| Functional Electrical Stimulation (FES)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). | Device | Standard FES + Standard Care |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Baseline to end of treatment (post-treatment; approximately 5-6 weeks)
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).
3 secondary outcomes
Movement Quality (SSMD Assessment Mode)
Time frame: Baseline to end of treatment (approximately 5-6 weeks)
EMG Signal Strength (Threshold)
Time frame: Baseline to end of treatment (approximately 5-6 weeks)
Functional Independence Measure (FIM)
Time frame: Baseline to end of treatment (approximately 5-6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.Boris Chelibian principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial StimelMD (SSMD) and Functional Electrical Stimulation (FES) in people with Stroke and Upper-limb Motor Impairment, run by Motion Informatics LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Lashinker (+972 525928545, victoria.lashinker@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Baseline to end of treatment (post-treatment; approximately 5-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.