Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Treatment: Photobiomodulation therapy (PBMt)
Intervention: Photobiomodulation therapy (PBMt) (Device)
Treatment: Photobiomodulation therapy (PBMt)
Intervention: Standard of Care (Other)
Control
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
Secondary Outcomes
- 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))
Investigators
Summer Ott, Psy.D.
Associate Professor
The University of Texas Health Science Center, Houston