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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Spinal Cord Injury; TBI; Peripheral Nerve Damage
• Intervention / Treatment: Device: SSMD; Device: Functional Electrical Stimulation (FES)

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Ustroń, Poland, 43-450
    • Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń
    • Contact: Dominika Baron; Phone Number: +48 887 357 334; Email: dominika.baron@ahop.pl
    • Contact: Krzysztof Baron; Phone Number: +48 533 512 512; Email: kbaron@clinpharm.pl
    • Principal Investigator: Krzysztof Santera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult men and women aged 18-80 years.
2. Clinically confirmed diagnosis of stroke, TBI, spinal cord injury, or peripheral nerve injury within the past 24 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., 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).
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSMD + Conventional Therapy; Participants receive SSMD sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks.	Device: SSMD; 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.
Active Comparator: FES + Conventional Therapy; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to post-treatment (end of treatment, 3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Baseline to post-treatment (end of treatment, Week 3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Active Range of Motion (AROM) measured by goniometer	Change from baseline to post-treatment in active range of motion (AROM) (0-70 degrees), measured by goniometer.	Baseline to post-treatment (end of treatment, Week 3)
Adverse events (AEs)	Frequency and severity of all adverse events (AEs), related or unrelated to study treatment.	Baseline through end of follow-up (up to 6 weeks)
Change in Modified Ashworth Scale (MAS)	Change from baseline to post-treatment in spasticity as measured by the Modified Ashworth Scale (range 0-4; higher scores indicate greater spasticity and worse outcome). Time Frame: Baseline to end of treatment (Week 3).	Baseline to post-treatment (end of treatment, Week 3)
Change in Stroke Impact Scale (SIS) score	Change from baseline to post-treatment in Stroke Impact Scale (SIS) score (range 0-100; higher scores indicate better function and less stroke impact). Time Frame: Baseline to end of treatment (Week 3).	Baseline to post-treatment (end of treatment, Week 3)
Change in NIH Stroke Scale (NIHSS) score	Change from baseline to post-treatment in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42; higher scores indicate more severe neurologic deficit and worse outcome). Time Frame: Baseline to end of treatment (Week 3).	Baseline to post-treatment (end of treatment, Week 3)
System Usability Scale (SUS) score	System usability assessed by the System Usability Scale (SUS) (range 0-100; higher scores indicate better usability). Time Frame: Post-treatment (Week 3).	Post-treatment (end of treatment, Week 3)
Observer usability questionnaire score	Observer-reported usability will be assessed using a custom Observer Usability Questionnaire evaluating effectiveness and efficiency of device use (e.g., task accuracy, ease of navigation, and assistance required). Questionnaire items are rated on a 5-point scale (1 = poorest performance/usability, 5 = best performance/usability). An overall usability score will be calculated as the mean of the rated items, with higher scores indicating better usability and task performance. Time Frame: Post-treatment (end of treatment, Week 3).	Post-treatment (end of treatment, Week 3)

Collaborators and Investigators

• Sponsor: Motion Informatics LTD

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Stroke; Spinal Cord Injuries; Neuritis
• Other Study ID Numbers: CP-SSMD-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No