Sports-related ConcussionNCT06239818
Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
A study testing Photobiomodulation therapy (PBMt) in people with Sports-related Concussion, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Sports-related Concussion
- What is being tested?
- Photobiomodulation therapy (PBMt)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Summer Ott, PsyD, (713) 486-3435, Summer.D.Ott@uth.tmc.edu
About this study
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
- Conditions
- Sports-related Concussion
- Being tested
- Photobiomodulation therapy (PBMt), Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Photobiomodulation therapy (PBMt) | Experimental | Not described Receives: Device: Photobiomodulation therapy (PBMt); Other: Standard of Care |
| Control | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (3-7 days post injury), Visit 3 (30 days post injury)
Secondary outcomes (8)
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start17 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports-related ConcussionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR/Mission Connect
- Responsible party
- Principal investigator, Summer Ott, Psy.D., The University of Texas Health Science Center, Houston
- Investigators
- Summer Ott, PsyD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239818
- Sponsor's protocol ID
- HSC-MS-23-0871
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
- ClinicalTrials.gov ID
- NCT06239818
- Acronym / sponsor ID
- HSC-MS-23-0871
- Conditions
- Sports-related Concussion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- TIRR/Mission Connect
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: Photobiomodulation therapy (PBMt) | Experimental | Device: Photobiomodulation therapy (PBMt), Other: Standard of Care |
| Control | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment: Photobiomodulation therapy (PBMt) |
| Standard of CareThe 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. | Other | Control, Treatment: Photobiomodulation therapy (PBMt) |
Primary outcome
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 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 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 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 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 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)
8 secondary outcomes
Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Summer Ott, PsyD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (PBMt) in people with Sports-related Concussion, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Summer Ott, PsyD ((713) 486-3435, Summer.D.Ott@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.