Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Cognitive Functioning_Learning/Memory
研究概览
简要总结
This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).
详细描述
The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
- •Meets criteria for mild TBI
- •LOC of 30 min or less
- •Age: 21-55
- •Primary language is English
排除标准
- •Evidence of penetrating head injury
- •History of previous neurological diagnosis
- •History of previous psychotic disorder prior to TBI
- •Hearing or vision impairment
研究组 & 干预措施
Active LED
Active LED Treatment
干预措施: LED (Other)
Sham LED
Inactive (sham) LED Treatment
干预措施: sham LED (Other)
结局指标
主要结局
Cognitive Functioning_Learning/Memory
时间窗: Eight weeks
California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, \& Ober, 2000)
Cognitive Functioning_Attention/Executive
时间窗: Eight Weeks
Stroop Test ("Color-Word" test; Delis, Kaplan \& Kramer, 2001)
次要结局
- Neuropsychiatric status/PTSD(Eight weeks)
- Neuropsychiatric status/Sleep(Eight weeks)
- Neuropsychiatric Status/Mood(Eight weeks)