StrokeNCT07396922
Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
A study testing SSMD and Functional Electrical Stimulation (FES) in people with Stroke and TBI, run by Motion Informatics LTD at 1 site in Poland.
Trial summary
This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, TBI, Spinal Cord Injury
- What is being tested?
- 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
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 30 Dec 2026to 30 Jan 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women aged 18-80 years.
- Clinically confirmed diagnosis of stroke, TBI, spinal cord injury, or peripheral nerve injury within the past 24 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., Cardiac demand pacemakers, Implantable pacemakers, Implantable cardioverter defibrillators, Implantable neurostimulators, Body-worn devices such as 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.
Poland1 site
Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń
Ustroń, 43-450
Dominika Baron, +48 887 357 334, dominika.baron@ahop.pl
Krzysztof Baron, +48 533 512 512, kbaron@clinpharm.pl
About this study
Official title: A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.
Read the detailed description
This is a clinical investigation of the Spatial StimeMD (SSMD) medical device in participants diagnosed with multiple sclerosis (MS). The purpose of the study is to evaluate the safety and performance of the device in a controlled clinical setting. Participants will be followed according to the study schedule and will undergo assessments of MS symptoms, physical function, and other relevant clinical outcomes. Safety will be assessed through monitoring of adverse events and other safety parameters throughout the study. Study data will be collected and reviewed according to the protocol, including verification against source documentation as required.
- Conditions
- Stroke, TBI, Spinal Cord Injury, Peripheral Nerve Damage
- Being tested
- SSMD, Functional Electrical Stimulation (FES)
- Medical subject headings
- Stroke, Spinal Cord Injuries, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSMDDevice
SSMD device-based therapy delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Functional Electrical Stimulation (FES)Device
Functional electrical stimulation (FES) delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SSMD + Conventional Therapy | Experimental | Participants receive SSMD sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks. Receives: Device: SSMD |
| FES + Conventional Therapy | Active comparator | Participants receive functional electrical stimulation (FES) sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks. Receives: Device: Functional Electrical Stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
Change from baseline in Fugl-Meyer Assessment Upper Extremity (Motor Function Subscale) The Fugl-Meyer Assessment Upper Extremity motor score is a clinician-rated measure of upper limb motor impairment following neurological injury. Scores range from 0 to 66, with higher scores representing less impairment and better motor function.
Time Frame: Baseline to post-treatment (3 weeks).
Measured: Baseline to post-treatment (end of treatment, 3 weeks)
Secondary outcomes (3)
change in Movement range and movement quality (SSMD assessment mode)
Change from baseline to post-treatment in movement range and movement quality as assessed using the SSMD system assessment mode.
Measured: Baseline to post-treatment (end of treatment, Week 3)
Change in Functional Independence Measure (FIM) score
Change from baseline to post-treatment in activities of daily living as measured by the Functional Independence Measure (FIM) total score (range 18-126, higher scores indicate greater independence and better functional outcome).
Time Frame: Baseline to end of treatment (Week 3).
Measured: Baseline to post-treatment (end of treatment, Week 3)
Change in EMG signal strength (threshold)
Change from baseline to post-treatment in electromyography (EMG) signal strength (threshold) during device-assisted assessment.
Measured: Baseline to post-treatment (end of treatment, Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (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 will be randomized (1:1) into two parallel groups to receive either SSMD plus conventional therapy or FES plus conventional therapy
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motion Informatics LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396922
- Sponsor's protocol ID
- CP-SSMD-02
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
- ClinicalTrials.gov ID
- NCT07396922
- Acronym / sponsor ID
- CP-SSMD-02
- Conditions
- Stroke, TBI, Spinal Cord Injury, Peripheral Nerve Damage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Motion Informatics LTDIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 9 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 study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.
Detailed description
This is a clinical investigation of the Spatial StimeMD (SSMD) medical device in participants diagnosed with multiple sclerosis (MS). The purpose of the study is to evaluate the safety and performance of the device in a controlled clinical setting. Participants will be followed according to the study schedule and will undergo assessments of MS symptoms, physical function, and other relevant clinical outcomes. Safety will be assessed through monitoring of adverse events and other safety parameters throughout the study. Study data will be collected and reviewed according to the protocol, including verification against source documentation as required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized (1:1) into two parallel groups to receive either SSMD plus conventional therapy or FES plus conventional therapy
| Arm | Type | Receives |
|---|---|---|
| SSMD + Conventional Therapy | Experimental | Device: SSMDParticipants receive SSMD sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks. |
| FES + Conventional Therapy | Active comparator | Device: Functional Electrical Stimulation (FES)Participants receive functional electrical stimulation (FES) sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult men and women aged 18-80 years.
- Clinically confirmed diagnosis of stroke, TBI, spinal cord injury, or peripheral nerve injury within the past 24 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., Cardiac demand pacemakers, Implantable pacemakers, Implantable cardioverter defibrillators, Implantable neurostimulators, Body-worn devices such as 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 |
|---|---|---|
| SSMDSSMD device-based therapy delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks. | Device | SSMD + Conventional Therapy |
| Functional Electrical Stimulation (FES)Functional electrical stimulation (FES) delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks. | Device | FES + Conventional Therapy |
Primary outcome
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
Time frame: Baseline to post-treatment (end of treatment, 3 weeks)
Change from baseline in Fugl-Meyer Assessment Upper Extremity (Motor Function Subscale) The Fugl-Meyer Assessment Upper Extremity motor score is a clinician-rated measure of upper limb motor impairment following neurological injury. Scores range from 0 to 66, with higher scores representing less impairment and better motor function. Time Frame: Baseline to post-treatment (3 weeks).
3 secondary outcomes
change in Movement range and movement quality (SSMD assessment mode)
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in Functional Independence Measure (FIM) score
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in EMG signal strength (threshold)
Time frame: Baseline to post-treatment (end of treatment, Week 3)
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: Undecided
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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.
Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń
Ustroń, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSMD and Functional Electrical Stimulation (FES) in people with Stroke and TBI, run by Motion Informatics LTD at 1 site in Poland.
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: opening soon, 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score (time frame: Baseline to post-treatment (end of treatment, 3 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.