Concussion, BrainRSiCCNCT05825027
Risk Stratification in Children With Concussion
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Duke University at 1 site in United States.
Trial summary
This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Concussion, Brain, Mild Traumatic Brain Injury
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 28 Feb 2028
- Phase
- Observational
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects will be recruited from concussion clinics in the Raleigh-Durham metro area of North Carolina.
Who may be able to join
- Diagnosed with concussion that occurred within the past 7 days
- Glasgow Coma Scale (GCS) score between 13-15
- English speaking
Who cannot join
- Diagnosed with moderate or severe traumatic brain injury
- Polytrauma
- Nontraumatic brain injury
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Fitterer, MPH contact
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Clinical Research Coordinator
About this study
Official title: A Risk Stratification Model for Health and Academic Outcomes in Children With Concussion Based on Novel Symptom Trajectory Typologies
This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Findings will provide novel insights into the longer-term effects of concussion on children's physical, psychological, and social well-being and support the development of personalized healthcare and school-based plans to reduce disparities in children's ability to return-to-learn and -play and improve postconcussion quality of life.
Read the detailed description
Concussions occur at an alarming rate among U.S. schoolchildren, with one in five children experiencing a concussion by age 16. The number of children visiting emergency departments for concussions annually has increased by 50% over the past decade, with an estimated cost to the healthcare system of $1 billion/year. Compared to adults, children experience longer and more severe postconcussive symptoms (PCS). Severity and duration of PCS, however, vary considerably among children, complicating clinical care and return to learn and play. Persistent PCS including physical, emotional, and cognitive symptoms, result in increased school absenteeism, social isolation, and psychological distress. Early PCS diagnosis and access to evidence-based return-to-health and -school interventions are strongly linked to positive health and academic outcomes. Yet models to identify children at high risk for persistent PCS are lacking. PCS have been linked to inflammatory processes occurring within the injured brain. Preliminary evidence suggests that fatigue, another symptom likely contributing to poor outcomes, is also a biological byproduct of pediatric concussions. Importantly, even though 73% of children report continuous fatigue after concussion, this symptom is rarely studied along with other PCS. Prior research has focused on the relationship between inflammatory biomarkers and PCS severity but has not examined this relationship longitudinally. Acute symptom severity alone, however, is a poor prognostic of clinical outcomes in concussed children. Symptom severity immediately postinjury does not explain why at least 25% of children still experience PCS after 1 year or why even children who may appear asymptomatic still report academic and social challenges months after concussion. To identify which children are at high risk for persistent PCS and poor health, academic, and social outcomes, research tracking PCS trajectories and describing school-based impacts across the entire first year postinjury is critically needed. This proposal will 1) define novel PCS trajectory typologies in a racially/ethnically diverse population of 500 children with concussion (11-17 years, near equal distribution by sex), 2) identify associations between these typologies and patterns of inflammatory biomarkers, 3) develop a risk stratification model to identify children at risk for persistent PCS; and 4) gain unique insights and describe PCS impact, including fatigue, on longer-term academic and social outcomes. We will be the first to use NIH's symptom science model and patient-reported outcomes to explore the patterns of fatigue and other physical, cognitive, psychological, emotional and academic responses to concussion in children over a full year. Our model will enable clinicians and educators to identify children most at risk for poor long-term health, social, and academic outcomes after concussion. This work is critical to meeting our long-term goal of developing personalized concussion symptom management strategies to improve outcomes and reduce disparities in the health and quality of life of children.
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Medical subject headings
- Brain Concussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concussion symptom burden and severity as measured by the Post Concussion Symptom Scale (PCSS)
The PCSS consists of 22 questions that relate to post-concussive symptoms. Survey-takers are asked to rate each symptom according to a 7-point Likert scale ranging from 0-6. Higher scores indicate a higher severity of post-concussive symptoms. The greatest possible score is 132 and the lowest possible score is 0.
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Change in post concussion fatigue burden and severity as measured by the PROMIS Pediatric Item Bank v2.0 - Fatigue
The PROMIS Pediatric Fatigue item bank consists of 25 self-report items which measure fatigue symptoms in children aged 8-17 years. Items are ranked on a 5-point likert scale ranging from 1 (Never) to 5 (Almost Always). Raw scores are converted to T-scores using scoring tables. A T-score of 50 is the average for the United States general population. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a T-score of 60 is one SD worse greater degree of fatigue than average. By comparison, a fatigue T-score of 40 is one SD better lesser degree of fatigue than average.
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Change in degree of involvement with one's peers in usual social roles, activities and responsibilities as measured by the Neuro-QoL Item Bank v1.0 - Pediatric Social Relations - Interaction with Peers
This instrument consists of 8 self-report items focused on patient-reported involvement with peers in usual social roles, activities, and responsibilities. Items are rated on a 5-point likert scale ranging from 1 (Never Interacting) to 5 (Always Interacting). Raw scores are converted to T-scores using conversion tables, with a T-score of 50 as the mean. A higher Neuro-QoL T-score represents more of the concept being measured. For positively-worded concepts this measure, a T-score of 40 is one SD worse less interaction with peers than average. By comparison, a fatigue T-score of 60 is one SD better more interaction with peers than average.
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Change in perceived difficulties in everyday cognitive abilities such as memory, attention, concentration, processing speed and organization skill as measured by the Neuro-QoL Item Bank v2.0 - Pediatric Cognitive Function
This instrument consists of 8 self-report items focused on patient-reported difficulties with basic cognitive abilities such as memory, attention, concentration, processing speed, and organization skill. Items are rated on a 5-point likert scale ranging from 1 (Not at all) to 5 (Very much). Raw scores are converted to T-scores using conversion tables, with a T-score of 50 as the mean. A higher Neuro-QoL T-score represents more of the concept being measured. For cognitive function, a T-score of 40 is one SD less difficulty than average. By comparison, a T-score of 60 is one SD more difficulty than average .
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Change in academic needs of a student following concussion as measured by the Concussion Learning Assessment & School Survey, 3rd Edition (CLASS-3)
This measure consists of four scale scores (General Academic Concern, Academic Problems, School Stresses, and Academic Subjects) and a cumulative score is generated for each of the 4 scales [0-3 - General Academic Concern (1 item, total score range 0-3), Academic Problems (14 items, total score range 0-42), School Stresses (6 items, total score range 0-6); 0-4 - Academic Subjects (4 items, total score range 0-16)], which in sum can be considered as a clinical measure to assess and monitor the academic needs of a student following concussion. Higher scores correlate with greater difficulty with academic needs.
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary Interferon Gamma
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary Interleukin-1 Beta
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary Interleukin-6
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary Interleukin-8
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary Interleukin-10
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary TNF-Alpha
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Pubertal status
Salivary DHEA concentration
The high levels of DHEA that are secreted beginning in mid-childhood (~8 years of age) serve as a marker of adrenarche (puberty). DHEA level rises before external physical changes of puberty become obvious. Levels of DHEA in saliva have been shown to be a reliable index of blood levels in children and adolescents and are not dependent on time of day. DHEA age/sex-based reference ranges will be used to determine pubertal maturation. The assay results range from 10.2 pg/mL to 1000 pg/mL with higher levels correlating with later Tanner stages of puberty.
Measured: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Presence of genetic variants in genes that code for inflammatory cytokines
Inflammatory genetic variants involved in brain injury and in fatigue in the following genes:
APOE, IGSF3, IFN-γ, IL-1β, IL-6, IL-8, IL-10, MAPT, TNF-α, TNFAIP1, TNFAIP8
Measured: Within 7 days of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start23 May 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Karin Reuter-Rice, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825027
- Sponsor's protocol ID
- Pro00111606
- Other IDs
- R01NS129617
- Acronym
- RSiCC
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reuter-Rice K, Fitterer AN, Duquette P, Yang Q, Palipana AK, Laskowitz D, Garrett ME, Fletcher M, Smith J, Makor L, Grant G, Ramsey K, Bloom OJ, Ashley-Koch AE. A study protocol for risk stratification in children with concussion (RSiCC): Theoretical framework, design, and methods. PLoS One. 2024 Jul 18;19(7):e0306399. doi: 10.1371/journal.pone.0306399. eCollection 2024.
PubMed 39024215
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk Stratification Model for Health and Academic Outcomes in Children With Concussion Based on Novel Symptom Trajectory Typologies
- ClinicalTrials.gov ID
- NCT05825027
- Acronym / sponsor ID
- RSiCC / Pro00111606
- Conditions
- Concussion, Brain, Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 24 Apr 2023 (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.
This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Findings will provide novel insights into the longer-term effects of concussion on children's physical, psychological, and social well-being and support the development of personalized healthcare and school-based plans to reduce disparities in children's ability to return-to-learn and -play and improve postconcussion quality of life.
Detailed description
Concussions occur at an alarming rate among U.S. schoolchildren, with one in five children experiencing a concussion by age 16. The number of children visiting emergency departments for concussions annually has increased by 50% over the past decade, with an estimated cost to the healthcare system of $1 billion/year. Compared to adults, children experience longer and more severe postconcussive symptoms (PCS). Severity and duration of PCS, however, vary considerably among children, complicating clinical care and return to learn and play. Persistent PCS including physical, emotional, and cognitive symptoms, result in increased school absenteeism, social isolation, and psychological distress. Early PCS diagnosis and access to evidence-based return-to-health and -school interventions are strongly linked to positive health and academic outcomes. Yet models to identify children at high risk for persistent PCS are lacking. PCS have been linked to inflammatory processes occurring within the injured brain. Preliminary evidence suggests that fatigue, another symptom likely contributing to poor outcomes, is also a biological byproduct of pediatric concussions. Importantly, even though 73% of children report continuous fatigue after concussion, this symptom is rarely studied along with other PCS. Prior research has focused on the relationship between inflammatory biomarkers and PCS severity but has not examined this relationship longitudinally. Acute symptom severity alone, however, is a poor prognostic of clinical outcomes in concussed children. Symptom severity immediately postinjury does not explain why at least 25% of children still experience PCS after 1 year or why even children who may appear asymptomatic still report academic and social challenges months after concussion. To identify which children are at high risk for persistent PCS and poor health, academic, and social outcomes, research tracking PCS trajectories and describing school-based impacts across the entire first year postinjury is critically needed. This proposal will 1) define novel PCS trajectory typologies in a racially/ethnically diverse population of 500 children with concussion (11-17 years, near equal distribution by sex), 2) identify associations between these typologies and patterns of inflammatory biomarkers, 3) develop a risk stratification model to identify children at risk for persistent PCS; and 4) gain unique insights and describe PCS impact, including fatigue, on longer-term academic and social outcomes. We will be the first to use NIH's symptom science model and patient-reported outcomes to explore the patterns of fatigue and other physical, cognitive, psychological, emotional and academic responses to concussion in children over a full year. Our model will enable clinicians and educators to identify children most at risk for poor long-term health, social, and academic outcomes after concussion. This work is critical to meeting our long-term goal of developing personalized concussion symptom management strategies to improve outcomes and reduce disparities in the health and quality of life of children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from concussion clinics in the Raleigh-Durham metro area of North Carolina.
Key inclusion criteria (3 listed)
- Diagnosed with concussion that occurred within the past 7 days
- Glasgow Coma Scale (GCS) score between 13-15
- English speaking
Key exclusion criteria (4 listed)
- Diagnosed with moderate or severe traumatic brain injury
- Polytrauma
- Nontraumatic brain injury
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in concussion symptom burden and severity as measured by the Post Concussion Symptom Scale (PCSS)
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
The PCSS consists of 22 questions that relate to post-concussive symptoms. Survey-takers are asked to rate each symptom according to a 7-point Likert scale ranging from 0-6. Higher scores indicate a higher severity of post-concussive symptoms. The greatest possible score is 132 and the lowest possible score is 0.
Change in post concussion fatigue burden and severity as measured by the PROMIS Pediatric Item Bank v2.0 - Fatigue
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
The PROMIS Pediatric Fatigue item bank consists of 25 self-report items which measure fatigue symptoms in children aged 8-17 years. Items are ranked on a 5-point likert scale ranging from 1 (Never) to 5 (Almost Always). Raw scores are converted to T-scores using scoring tables. A T-score of 50 is the average for the United States general population. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a T-score of 60 is one SD worse greater degree of fatigue than average. By comparison, a fatigue T-score of 40 is one SD better lesser degree of fatigue than average.
Change in degree of involvement with one's peers in usual social roles, activities and responsibilities as measured by the Neuro-QoL Item Bank v1.0 - Pediatric Social Relations - Interaction with Peers
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
This instrument consists of 8 self-report items focused on patient-reported involvement with peers in usual social roles, activities, and responsibilities. Items are rated on a 5-point likert scale ranging from 1 (Never Interacting) to 5 (Always Interacting). Raw scores are converted to T-scores using conversion tables, with a T-score of 50 as the mean. A higher Neuro-QoL T-score represents more of the concept being measured. For positively-worded concepts this measure, a T-score of 40 is one SD worse less interaction with peers than average. By comparison, a fatigue T-score of 60 is one SD better more interaction with peers than average.
Change in perceived difficulties in everyday cognitive abilities such as memory, attention, concentration, processing speed and organization skill as measured by the Neuro-QoL Item Bank v2.0 - Pediatric Cognitive Function
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
This instrument consists of 8 self-report items focused on patient-reported difficulties with basic cognitive abilities such as memory, attention, concentration, processing speed, and organization skill. Items are rated on a 5-point likert scale ranging from 1 (Not at all) to 5 (Very much). Raw scores are converted to T-scores using conversion tables, with a T-score of 50 as the mean. A higher Neuro-QoL T-score represents more of the concept being measured. For cognitive function, a T-score of 40 is one SD less difficulty than average. By comparison, a T-score of 60 is one SD more difficulty than average .
Change in academic needs of a student following concussion as measured by the Concussion Learning Assessment & School Survey, 3rd Edition (CLASS-3)
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
This measure consists of four scale scores (General Academic Concern, Academic Problems, School Stresses, and Academic Subjects) and a cumulative score is generated for each of the 4 scales [0-3 - General Academic Concern (1 item, total score range 0-3), Academic Problems (14 items, total score range 0-42), School Stresses (6 items, total score range 0-6); 0-4 - Academic Subjects (4 items, total score range 0-16)], which in sum can be considered as a clinical measure to assess and monitor the academic needs of a student following concussion. Higher scores correlate with greater difficulty with academic needs.
Salivary Interferon Gamma
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Salivary Interleukin-1 Beta
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Salivary Interleukin-6
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Salivary Interleukin-8
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Salivary Interleukin-10
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Salivary TNF-Alpha
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary levels of inflammatory cytokine associated with post concussive symptoms
Pubertal status
Time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury
Salivary DHEA concentration The high levels of DHEA that are secreted beginning in mid-childhood (~8 years of age) serve as a marker of adrenarche (puberty). DHEA level rises before external physical changes of puberty become obvious. Levels of DHEA in saliva have been shown to be a reliable index of blood levels in children and adolescents and are not dependent on time of day. DHEA age/sex-based reference ranges will be used to determine pubertal maturation. The assay results range from 10.2 pg/mL to 1000 pg/mL with higher levels correlating with later Tanner stages of puberty.
Presence of genetic variants in genes that code for inflammatory cytokines
Time frame: Within 7 days of injury
Inflammatory genetic variants involved in brain injury and in fatigue in the following genes: APOE, IGSF3, IFN-γ, IL-1β, IL-6, IL-8, IL-10, MAPT, TNF-α, TNFAIP1, TNFAIP8
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 8 Jul 2026.
- Background: PubMed 39024215Reuter-Rice K, Fitterer AN, Duquette P, Yang Q, Palipana AK, Laskowitz D, Garrett ME, Fletcher M, Smith J, Makor L, Grant G, Ramsey K, Bloom OJ, Ashley-Koch AE. A study protocol for risk stratification in children with concussion (RSiCC): Theoretical framework, design, and methods. PLoS One. 2024 Jul 18;19(7):e0306399. doi: 10.1371/journal.pone.0306399. eCollection 2024.
- 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.
Amanda Fitterer, MPH contact
Karin Reuter-Rice, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Mild Traumatic Brain Injury, run by Duke University 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 3 inclusion and 4 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 8 Jul 2026. 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 Karin Reuter-Rice, PhD (919-681-7647, karin.reuter-rice@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concussion symptom burden and severity as measured by the Post Concussion Symptom Scale (PCSS) (time frame: Within 7 days of injury, 30 days post injury, 90 days post injury, 180 days post injury, 270 days post injury and 360 days post injury). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825027, which also lists 1 linked publication.
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 8 Jul 2026.