NCT01120301已完成3 期
NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 118
- 主要终点
- Adverse event differences between transcranial laser therapy and sham
研究概览
简要总结
The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke
- •Subject is not a candidate for treatment with neurothrombectomy
- •Initiation of the TLT procedure begins between 4.5 and 24 hours
- •Baseline NIHSS score range: 7-17
- •Full functional independence just prior to the present stroke episode
- •Negative pregnancy test in females of childbearing potential
- •Subject Informed Consent obtained prior to enrollment into this study
排除标准
- •Evidence of an intracranial, subdural, or subarachnoid hemorrhage
- •Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
- •Seizure at stroke onset or within the 7 days prior to stroke onset
- •Sustained blood glucose >300 or <60 mg/dl
- •Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg)
- •Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg)
- •A presumed and/or confirmed septic embolus
- •History of CNS vascular disease (e.g. aneurysm, AVM) or history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject's outcome assessment.
- •Head implant of any kind
- •Significant skin condition of the scalp (eg. psoriasis)
- •Use of any intravenous or intra-arterial thrombolytic medication
- •Use of any diagnostic or therapeutic interventional neurovascular procedure
- •Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.
结局指标
主要结局
Adverse event differences between transcranial laser therapy and sham
时间窗: Day 90
Disability assessed using the dichotomous modified Rankin Scale (mRS)
时间窗: Day 90
次要结局
- Distribution of scores across the ordinal mRS(Day 90)
- Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)(Day 90)
研究者
研究点 (118)
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