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| Name | Class |
|---|---|
| TIRR/Mission Connect | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: Photobiomodulation therapy (PBMt) | Experimental |
| |
| Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation therapy (PBMt) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale | 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. | 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 | 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. | 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 | 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. | 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) | The Total Sleep Quality Score will be reported, and it ranges from 1 to 6. A higher score indicates better sleep quality. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test | Composite score on the Verbal Memory component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 100, with a higher score indicating a better outcome. | Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Summer Ott, PsyD | Contact | (713) 486-3435 | Summer.D.Ott@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Summer Ott, PsyD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D019984 | Quality Indicators, Health Care |
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| Standard of Care | Other | 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. Physical and cognitive activities can be progressively resumed at a pace that does not worse existing or create new symptoms. Education, return to activity advice, and symptom management are all reviewed in subsequent visits as needed. |
|
| 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 | 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 | 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 | Baseline (3-7 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 | Composite score on the Visual Memory component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 100, with a higher score indicating a better outcome. | 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 | Composite score on the Visual Motor Speed component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 50, with a higher score indicating a better outcome. | 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 | Composite score on the Reaction Time component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 1.50, with a lower time indicating a better outcome. | 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 | Composite score on the Impulse Control component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 30, with a lower score indicating a better outcome. | 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 | This is an 8 item questionnaire, and each item is scored from 1 (very much) to 5 (not at all), for a total score range of 8 to 40 and with a higher score indicating a better outcome. | 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 | This is an 8 item questionnaire, and each item is scored from 1 (never) to 5 (always), for a total score range of 8 to 40 and with a higher score indicating more stress. | 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 | This is a 7 item questionnaire, and each item is score from 1 to 5, for a total score range of 7 to 35 and with a higher score indicating a better outcome. | Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury) |
| D011787 |
| Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |