Transcranial LED Therapy for the Treatment of Chronic Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.
研究概览
简要总结
A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo therapy (controls) or treatment with LED therapy (cases). Both cases and controls would complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms resolve before the end of the 6 week period.
详细描述
Concussion, also known as mild traumatic brain injury (mTBI), results from a rotational acceleration of the brain. The biomechanical forces which cause concussion lead to the opening of ion channels within the neuronal cell membranes, allowing for a massive influx of sodium and efflux of potassium. This results in a spreading depression type of phenomenon, leading to the depolarization of neurons diffusely throughout the brain.19 In order to restore the homeostatic ion gradients across the membrane, the sodium-potassium pumps require increasing amounts of adenosine triphosphate (ATP). Thus, there is an increased need for ATP after concussion. ATP is supplied by the glycolysis of glucose from the blood stream. Both experimental models of concussion and human studies, however, show decreased cerebral blood flow after the initial response to injury. Thus, there is an increased demand for ATP after concussion; but a diminished supply of glucose to meet the demand.
The absorption of light in the red/near infrared wavelength spectrum by cytochrome C oxidase increases ATP synthesis. Thus, by increasing ATP synthesis, red/near infrared LEDs can treat the underlying pathophysiological cause of concussion symptoms. If successful, this would be the first therapy to directly treat the underlying pathophysiology of concussion.
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
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 11 years old or greater
- •Diagnosed with a concussion whose symptoms have persisted for more than 4 weeks
- •Total score on the cognitive components of the post-concussion symptom scale exceeds 9, or if they have a composite score on any one of the 4 main outputs of the computerized neurocognitive assessment: Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) that is below the 90th percentile for their age.
排除标准
- •Clinically indicated imaging has been obtained where a hemorrhage is demonstrated
- •Being considered for an alternate diagnosis (other than concussion)
- •Have a pre-injury diagnosis of any of the following: depression, post-traumatic stress disorder, other psychiatric disorder
- •Taking any of the following medications: amantadine, , amphetamine, atomoxetine
研究组 & 干预措施
MedX Health Console model 1100
The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. All treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.
干预措施: MedX Health Console model 1100 (Device)
MedX Health Console model 1100-placebo
Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. All placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.
干预措施: MedX Health Console model 1100-placebo (Device)
结局指标
主要结局
Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.
时间窗: From baseline to 6 weeks
The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.
次要结局
- Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6.(From baseline to 3 weeks and from baseline to 6 weeks)
- Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6.(From baseline to 3 weeks and from baseline to 6 weeks)
- Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6(From baseline to 3 weeks and from baseline to 6 weeks)
- Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6.(From baseline to 3 weeks and from baseline to 6 weeks)
研究者
William Meehan III
MD, Director of Research - Sports Medicine
Boston Children's Hospital