Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)
研究概览
简要总结
The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to standard of care in adolescent athletes at risk for delayed recovery from subacute sports concussion, to substantiate the impact of subacute PBMt over time on functional and structural connectivity of the brain using advanced MRI sequences and to correlate the psychological and behavioral outcomes to neuroimaging findings
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
- Single (Investigator)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current participants in a school- or club-sponsored sport (contact or non-contact)
- •access to wireless internet service at home
- •diagnosis of sports-related concussion (SRC) (according to consensus diagnostic criteria) by a licensed healthcare provider,3-7 days from the concussive injury at the time of enrolment
- •considered at-risk for protracted recovery based on Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) performance and symptom reporting on the Post-Concussion Symptom Scale (PCSS)
排除标准
- •acute neurologic deterioration to a Glasgow Coma Scale score less than 13
- •neurosurgical intervention
- •abnormal CT scan
- •concomitant extracranial injury worse than mild
- •pre-injury conditions which confound effects of SRC (e.g., epilepsy, schizophrenia, bipolar illness, mental deficiency, hospitalization for TBI)
- •substance dependence
- •inability to speak fluent English
- •Individuals who are taking benzodiazepines, anti-convulsants, mood stabilizers, stimulants, opioids, sleep aids, or other neuropsychiatric medications
研究组 & 干预措施
Treatment: Photobiomodulation therapy (PBMt)
干预措施: Photobiomodulation therapy (PBMt) (Device)
Treatment: Photobiomodulation therapy (PBMt)
干预措施: Standard of Care (Other)
Control
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)
时间窗: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
The Total Sleep Quality Score will be reported, and it ranges from 1 to 6. A higher score indicates better sleep quality.
Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale
时间窗: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
This is an 8 item questionnaire, and each item is scored on a 5 point Likert scale from 1 (never) to 5 (almost always), for a total score range of 8 to 40 and with a higher score indicating a worse outcome.
Change in Diffusion Tensor Image Analysis Along the Perivascular Space (DTI-ALPS) as assessed by MRI of the brain
时间窗: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
Change in anxiety as assessed by the Neuro-QoL Short Form v1.0 - Pediatric Anxiety scale
时间窗: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
This is an 8 item questionnaire, and each item is scored on a 5 point Likert scale from 1 (never) to 5 (almost always), for a total score range of 8 to 40 and with a higher score indicating a worse outcome.
Change in intensity of post-concussion symptoms as assessed by Total Symptom Score on the Post-Concussion Symptoms Scale (PCSS) of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Concussion Test
时间窗: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
The PCSS of the ImPACT Concussion Test consists of a list of 22 symptoms for which participants rate the intensity of a symptom from 0 (none) to 6 (severe), for a Total Symptom Score range of 0 to 132 and with a higher score indicating a higher symptom total.
Change in brain volume as assessed by Magnetic Resonance Imaging (MRI) of the brain
时间窗: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
Change in Fractional Anisotropy (FA) of compact white matter as assessed by MRI of the brain
时间窗: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
Change in Radial Diffusivity (RD) of compact white matter as assessed by MRI of the brain
时间窗: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
次要结局
- Change in cognitive function as assessed by composite score on the Visual Memory component of the ImPACT Concussion Test(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in cognitive function as assessed by composite score on the Visual Motor Speed component of the ImPACT Concussion Test(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in cognitive function as assessed by composite score on the Reaction Time component of the ImPACT Concussion Test(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in cognitive function as assessed by composite score on the Impulse Control component of the ImPACT Concussion Test(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in quality of life as assessed by the PROMIS Pediatric Scale v1.0 - Global Health 7 scale(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in cognitive function as assessed by the Neuro-QoL Short Form v2.0 - Pediatric Cognitive Function scale(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
- Change in stress as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form v1.0 - Psychological Stress Experiences 8a scale(Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury))
研究者
Summer Ott, Psy.D.
Associate Professor
The University of Texas Health Science Center, Houston