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

NCT07396922 | Not Yet Recruiting

• 1 other identifier: CP-SSMD-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.

Conditions

Stroke; TBI; Spinal Cord Injury; Peripheral Nerve Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in Movement range and movement quality (SSMD assessment mode)

  Baseline to post-treatment (end of treatment, Week 3)

• Change in Functional Independence Measure (FIM) score

  Baseline to post-treatment (end of treatment, Week 3)

• Change in EMG signal strength (threshold)

  Baseline to post-treatment (end of treatment, Week 3)

Other Outcomes (7)

• Change in Modified Ashworth Scale (MAS)

  Baseline to post-treatment (end of treatment, Week 3)

• Change in Stroke Impact Scale (SIS) score

  Baseline to post-treatment (end of treatment, Week 3)

• Change in NIH Stroke Scale (NIHSS) score

  Baseline to post-treatment (end of treatment, Week 3)

Study Arms (2)

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.

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.

Device: Functional Electrical Stimulation (FES)

Interventions

SSMD DEVICE

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.

SSMD + Conventional Therapy

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.

FES + Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Motion Informatics LTD: lead

Study Sites (1)

Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń

Ustroń, 43-450, Poland

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Neuritis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No masking/blinding is implemented due to the nature of the device interventions and treatment delivery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized (1:1) into two parallel groups to receive either SSMD plus conventional therapy or FES plus conventional therapy

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

PL (1)