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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Sports-related Concussion

Treatments

Device: Photobiomodulation therapy (PBMt)
Other: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT06239818
HSC-MS-23-0871

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Treatment: Photobiomodulation therapy (PBMt)
Experimental group
Treatment:
Other: Standard of Care
Device: Photobiomodulation therapy (PBMt)
Control
Active Comparator group
Treatment:
Other: Standard of Care

Trial contacts and locations

1

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Central trial contact

Summer Ott, PsyD

Data sourced from clinicaltrials.gov

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