A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No masking/blinding is implemented due to the nature of the device interventions and treatment delivery
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: SSMD (Device)
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.
干预措施: Functional Electrical Stimulation (FES) (Device)
结局指标
主要结局
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
时间窗: 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).
次要结局
- 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))