Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Safety and Feasibility of Applying Light Therapy After Moderate TBI
研究概览
简要总结
The purpose of this research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (TBI).
详细描述
The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the response to LLLT through MR imaging and clinical outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •At least 18 years old;
- •Injury within 72 hours at the time of consent;
- •Head injury requiring hospital admission;
- •A Glasgow Coma Scale (GCS) score of 9-12 or 13-15 with abnormal imaging.
排除标准
- •Need for emergency neurosurgical intervention (including placement of intracranial pressure monitoring devices or drainage catheters);
- •Hemodynamic instability as determined by the clinician;
- •History of any of the following: (i) brain tumor; (ii) prior TBI occurring within the past year and requiring hospital admission; (iii) a new diagnosis within the past year of either stroke or epilepsy; (iv) an established diagnosis of any of the following neurodegenerative diseases: Alzheimer's, Picks, Parkinson's, Lewy body dementia, Huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia, HIZ-associated dementia, dementia due to metabolic causes (Addison, Cushing, hypothyroidism, renal failure, prophyrias, Wilson, mitochondrial diseases, Wernicke-Korsakoff syndrome, and dementia of unknown etiology.
- •Pregnancy (all women of child-bearing age will need to have a negative pregnancy test prior to the start of the interventional portion of the study);
- •Electrical implants such as cardiac pacemakers or perfusion pumps;
- •Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, or any other contra-indications to MRI.
- •Clinical determination that subject cannot undergo MRI
- •Breastfeeding
- •Unstable cervical fractures
- •Scalp lacerations or surgical wounds severe enough to preclude safe application of device
- •Unreliable to follow up
结局指标
主要结局
Safety and Feasibility of Applying Light Therapy After Moderate TBI
时间窗: up to seven days after enrollment
Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
次要结局
- Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)(up to 3 months after treatment)
- Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)(up to 3 months after treatment)
- Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function(RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.)
研究者
Rajiv Gupta
Principal Investigator
Massachusetts General Hospital