Biomarker Responsiveness of Nanopulse Laser Therapy in Treatment of Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of a novel noninvasive therapy, Nanopulse Laser Therapy (NPLT), to improve recovery following traumatic brain injury (TBI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
盲法说明
This will be a single-blind study. Participants (or their representatives) will be blinded to group assignment. Treating clinicians cannot be blinded due to the nature of the intervention, but they will not be involved in data collection or analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older at the time of enrollment
- •Confirmed diagnosis of moderate to severe TBI (clinical assessment and radiographic evidence)
- •Admission to the neurosurgical or neurocritical care service with anticipated need for intracranial monitoring (e.g., microdialysis, ICP probe)
- •Able to initiate treatment within 48 hours of admission
- •Informed consent obtained from patient or legally authorized representative
排除标准
- •Patients younger than 18 years of age
- •Known or suspected pregnancy (verified via urine pregnancy test for females of childbearing age)
- •Incarcerated individuals or prisoners
- •Patients with pre-existing implanted cranial devices (e.g., deep brain stimulators) that may interfere with NPLT
- •Patients with severe scalp injury or open wounds at intended treatment site
- •Known allergy or hypersensitivity to adhesives or device components
研究组 & 干预措施
Nano-Pulsed Laser Therapy (NPLT)
Participants receive NPLT administered transcranially.
干预措施: Nano-Pulsed Laser Therapy (NPLT) (Device)
Standard of Care with Sham NPLT
Participants receive standard care with sham NPLT (laser delivery obstructed but device setup identical).
结局指标
主要结局
Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury
时间窗: During the hospitalization for up to 6 days
Feasibility will be assessed by the successful administration of NPLT acutely following moderate to severe traumatic brain injury, including protocol adherence and completion of the intervention.
Acute Physiological Effects of Nano-Pulsed Laser Therapy (NPLT)
时间窗: During the hospitalization for up to 6 days
Acute physiological effects will be evaluated by changes in predefined physiological parameters measured before and after NPLT administration during the acute post-injury period.
次要结局
未报告次要终点