Brain Injury, TraumaticmTBINCT01688869
Mild Traumatic Brain Injury Registry
An observational study of Brain Injury, Traumatic, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Brain Injury, Traumatic
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jan 2015
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are seen in the CMC emergency department who have a clearly defined history of traumatic brain injury that produced at least transient alteration in consciousness, or change in mood, together with one or more persistent symptom lasting longer than one hour after impact. Symptoms can include head pain, nausea, dizziness, disequilibrium, confusion, amnesia, or irritability. All patients must be awake and alert (GCS 13 to 15), and must be enrolled within 72 hours of the injury.
Who may be able to join
- Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood
- Must be awake and alert (Glasgow Coma Scale 13-15)
- Must be enrolled within 72 hours of injury
- Must have CT or MRI neuroimaging performed
Who cannot join
- Diabetes Mellitus with severe complications
- Intoxication at time of enrollment
- Major psychiatric disorder that is poorly controlled
- Prior stroke
- History of Social Security defined "disability
- Uncontrolled Seizure Disorder
Show all 17Show fewer
- Incarceration or arrest
- Concurrent Injury requiring hospitalization
- Use of anticoagulant drugs
- Any condition the investigator deems as inappropriate for patient enrollment
- Personality disorder
- Heart, liver or kidney failure defined using common clinical practice guidelines
- Baseline cognitive impairment
- Homelessness
- TBI associated with interpersonal violence
- Pregnancy
- Long bone fracture requiring surgical stabilization
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.
Read the detailed description
The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.
- Conditions
- Brain Injury, Traumatic
- Keywords
- brain concussion
- Medical subject headings
- Brain Injuries, Traumatic, 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 |
|---|---|---|
| Mild TBI | Patients who have been diagnosed with a mild brain injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, TraumaticStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori M Grafton, MD, Principal investigator, Wake Forest University Health SciencesMichael A Gibbs, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688869
- Sponsor's protocol ID
- 04-12-03A
- Acronym
- mTBI
- Status last verified
- Feb 2015
- First submitted
- 17 Sep 2012
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Traumatic Brain Injury Registry
- ClinicalTrials.gov ID
- NCT01688869
- Acronym / sponsor ID
- mTBI / 04-12-03A
- Conditions
- Brain Injury, Traumatic
- Keywords
- brain concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Sep 2012 (estimated)
- 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 the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.
Detailed description
The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild TBI | – | –Patients who have been diagnosed with a mild brain injury. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are seen in the CMC emergency department who have a clearly defined history of traumatic brain injury that produced at least transient alteration in consciousness, or change in mood, together with one or more persistent symptom lasting longer than one hour after impact. Symptoms can include head pain, nausea, dizziness, disequilibrium, confusion, amnesia, or irritability. All patients must be awake and alert (GCS 13 to 15), and must be enrolled within 72 hours of the injury.
Key inclusion criteria (4 listed)
- Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood
- Must be awake and alert (Glasgow Coma Scale 13-15)
- Must be enrolled within 72 hours of injury
- Must have CT or MRI neuroimaging performed
Key exclusion criteria (17 listed)
- Diabetes Mellitus with severe complications
- Intoxication at time of enrollment
- Major psychiatric disorder that is poorly controlled
- Prior stroke
- History of Social Security defined "disability
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
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Lori M Grafton, MD principal investigator
Wake Forest University Health Sciences
Michael A Gibbs, MD principal investigator
Wake Forest University Health Sciences
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 Brain Injury, Traumatic, run by Wake Forest University Health Sciences 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 17 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: finished, as of the sponsor's last update on 25 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury. (time frame: 6 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 25 Apr 2022.