Concussion, MildNCT05943561
Biomarkers in Concussion
An observational study of Concussion, Mild and Concussion, Intermediate, run by Medstar Health Research Institute.
Trial summary
This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Athletes with or without concussion.
Who may be able to join
- Over 12 years of age Athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study.
Who cannot join
- Existing active neurodegenerative disorder (ie severe TBI) Active peripheral nerve disorder (ie diabetic neuropathy)
Trial locations and contacts
No sites are listed yet.
About this study
This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Concussion | Has an acute concussion | |
| Non-concussion | Does not have a concussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of NfL levels
Measured: 12 weeks
Secondary outcomes (1)
Resolution of concussion symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Streicher, Medstar Health Research Institute
- Investigators
- Nicholas Streicher, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943561
- Sponsor's protocol ID
- STUDY00006198
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2023
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Concussion
- ClinicalTrials.gov ID
- NCT05943561
- Acronym / sponsor ID
- STUDY00006198
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Jul 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 will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion | – | –Has an acute concussion |
| Non-concussion | – | –Does not have a concussion |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Athletes with or without concussion.
Key inclusion criteria (1 listed)
- Over 12 years of age Athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study.
Key exclusion criteria (1 listed)
- Existing active neurodegenerative disorder (ie severe TBI) Active peripheral nerve disorder (ie diabetic neuropathy)
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
Normalization of NfL levels
Time frame: 12 weeks
1 secondary outcome
Resolution of concussion symptoms
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- 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. This study is not recruiting at the moment.
Nicholas Streicher principal investigator
Medstar Health Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild and Concussion, Intermediate, run by Medstar Health Research Institute.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Merrill (2028776607, emma.merrill@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of NfL levels (time frame: 12 weeks). 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 5 Sep 2023.