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

Официальное название

A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score [Срок оценки: Baseline to post-treatment (end of treatment, 3 weeks)]

Вторичные конечные точки (3)

• change in Movement range and movement quality (SSMD assessment mode) [Срок оценки: Baseline to post-treatment (end of treatment, Week 3)]
• Change in Functional Independence Measure (FIM) score [Срок оценки: Baseline to post-treatment (end of treatment, Week 3)]
• Change in EMG signal strength (threshold) [Срок оценки: Baseline to post-treatment (end of treatment, Week 3)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń — Ustroń

Идентификаторы

NCT: NCT07396922 · CP-SSMD-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗