Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents

Обзор

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

Вмешательства

• Устройство Photobiomodulation therapy (PBMt)
  Participants will be asked to use the photobiomodulation (PBM) device for 20 minutes, daily (e.g., Monday - Sunday) for a total of 30 days. The device will be preprogrammed and automatically switched off after 20 minutes.
• Другое Standard of Care
  The patient is provided with verbal and written education including what a mild traumatic brain injury (mTBI) is, favorable expectations for recovery, and advice about how to manage specific symptoms. Relative rest for the first 24-48 hours after an mTBI is recommended as the main goal is to alleviate symptoms and reduce demands on the brain. After an initial period of relative rest and symptom stabilization, patients are encouraged to gradually resume normal daily activities as tolerated. Physi

Первичные конечные точки

• Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale [Срок оценки: Baseline (3-7 days post injury), Visit 2 (10-14 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 [Срок оценки: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)]
• 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 [Срок оценки: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)]
• Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version) [Срок оценки: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)]
• Change in brain volume as assessed by Magnetic Resonance Imaging (MRI) of the brain [Срок оценки: Baseline (3-7 days post injury), Visit 3 (30 days post injury)]
• Change in Diffusion Tensor Image Analysis Along the Perivascular Space (DTI-ALPS) as assessed by MRI of the brain [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (3-7 days post injury), Visit 3 (30 days post injury)]

Вторичные конечные точки (8)

• Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test [Срок оценки: 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 Memory component of the ImPACT Concussion Test [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06239818 · HSC-MS-23-0871

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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