Clinical trial NCT06239818: Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
Official title: Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sports-related Concussion
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: TIRR/Mission Connect
First posted: 2024-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in anxiety as assessed by the Neuro-QoL Short Form v1.0 - Pediatric Anxiety scale
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: 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
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in brain volume as assessed by Magnetic Resonance Imaging (MRI) of the brain
timeFrame: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
measure: Change in Diffusion Tensor Image Analysis Along the Perivascular Space (DTI-ALPS) as assessed by MRI of the brain
timeFrame: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
measure: Change in Fractional Anisotropy (FA) of compact white matter as assessed by MRI of the brain
timeFrame: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
measure: Change in Radial Diffusivity (RD) of compact white matter as assessed by MRI of the brain
timeFrame: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
Secondary outcomes:
measure: Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in cognitive function as assessed by composite score on the Visual Memory component of the ImPACT Concussion Test
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in cognitive function as assessed by composite score on the Visual Motor Speed component of the ImPACT Concussion Test
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in cognitive function as assessed by composite score on the Reaction Time component of the ImPACT Concussion Test
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in cognitive function as assessed by composite score on the Impulse Control component of the ImPACT Concussion Test
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in cognitive function as assessed by the Neuro-QoL Short Form v2.0 - Pediatric Cognitive Function scale
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in stress as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form v1.0 - Psychological Stress Experiences 8a scale
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
measure: Change in quality of life as assessed by the PROMIS Pediatric Scale v1.0 - Global Health 7 scale
timeFrame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Summer Ott, PsyD
role: PRINCIPAL_INVESTIGATOR
References: