Concussion, BrainNCT03414242
Investigation of Neurocognitive Measures of Sport-Related Injury
A study testing Cervical spine musculature in people with Concussion, Brain, run by Mayo Clinic at 3 sites in United States.
Trial summary
The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Cervical spine musculature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Mar 2019to Dec 2028
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-30 year old competitive or recreational athletes
Who cannot join
- Pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment
- Recent exposure to head lice
- Known or suspected pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.
- Conditions
- Concussion, Brain
- Being tested
- Cervical spine musculature
- Keywords
- brain, concussion, neck, strength, sport, prevention
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical spine musculatureOther
Previously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program.
| Study group | Role | What they receive |
|---|---|---|
| Cervical spine musculature | Experimental | Not described Receives: Other: Cervical spine musculature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood metabolite profile
Blood metabolite profile change from baseline blood draws will be analyzed to determine what blood biomarkers (e.g. amino acids, glycerophospholipids (mg/dL) ) are most sensitive to the presence of a concussion.
Measured: Through study completion, an athletic season average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start12 Mar 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David B. Soma, Mayo Clinic
- Investigators
- David Soma, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414242
- Sponsor's protocol ID
- 17-006025
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2018
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Neurocognitive Measures of Sport-Related Injury
- ClinicalTrials.gov ID
- NCT03414242
- Acronym / sponsor ID
- 17-006025
- Conditions
- Concussion, Brain
- Keywords
- brain, concussion, neck, strength, sport, prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jan 2018 (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 overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical spine musculature | Experimental | Other: Cervical spine musculature |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 12-30 year old competitive or recreational athletes
Key exclusion criteria (3 listed)
- Pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment
- Recent exposure to head lice
- Known or suspected pregnancy
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 |
|---|---|---|
| Cervical spine musculaturePreviously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program. | Other | Cervical spine musculature |
Primary outcome
Change in blood metabolite profile
Time frame: Through study completion, an athletic season average of 4 months
Blood metabolite profile change from baseline blood draws will be analyzed to determine what blood biomarkers (e.g. amino acids, glycerophospholipids (mg/dL) ) are most sensitive to the presence of a concussion.
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 30 Jan 2026.
- 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.
David Soma, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical spine musculature in people with Concussion, Brain, run by Mayo Clinic at 3 sites 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood metabolite profile (time frame: Through study completion, an athletic season average of 4 months). 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 30 Jan 2026.