Traumatic Brain InjuryNCT02891941
Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Injury of Body Region, run by Johns Hopkins University at 1 site in United States.
Trial summary
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/mild traumatic brain injury (MTBI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Injury of Body Region
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2014
- How long will I take part?
- 6 Months
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency rooms, local physicians, free-standing urgent care establishments, local community
Who may be able to join
- Individuals with MTBI: Inclusion Criteria:
- Have sustained a closed head injury, defined as externally inflicted trauma without skull fracture;
- Have a Glasgow Coma Scale (GCS) score 13 or above
- Meet the American Congress of Rehabilitation Medicine criteria for mild traumatic brain injury
- Have experienced the last injury within 1 month
- Be in excellent/good medical health as assessed by the General Medical Health Rating (GMHR) scale
Show all 13Show fewer
- Have sufficient cognitive capacity to provide informed consent
- Be between 18-65 years of age and
- Be willing to have brain MRI and a blood draw,
- Individuals with Body Injury will meet inclusion criteria 4-8. Instead of criteria for head injury (1-3) they would have had body injury (defined as injury below the neck (e.g., limb fractures, stab wound abdomen).
- Age, and sex, matched normal controls: Inclusion Criteria:
- No history of head injury or any other types of brain injury
- Inclusion criteria 5-8
Who cannot join
- History of stroke, seizures or other pre-injury neurological diseases
- Mental Retardation
- History of skull fracture
- Presence of severe unstable medical disease
- Contraindications to the MRI brain scan
- Possibility of pregnancy
- Presence of communication difficulties, such as moderate to severe hearing or language impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/mild traumatic brain injury (MTBI).
Read the detailed description
This will be a prospective study of subjects with MTBI, body injury and healthy controls. Subjects who meet the study criteria will be enrolled in the study after they provide informed consent.
All subjects will be followed longitudinally at 3 and 6 months post-injury.
All subjects will have 3-4 visits:
Screening visit to determine eligibility; first study visit within 1 month of injury for those with brain or body injury (at the time of screening or within 1 month of screening for healthy controls); second study visit at 3 months post-injury (3 months after the first visit for healthy controls) and third study visit at 6 months post-injury (6 months after the first visit for healthy controls).
- Conditions
- Traumatic Brain Injury, Injury of Body Region
- Medical subject headings
- Brain Injuries, Traumatic
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 Traumatic Brain Injury | This cohort will have sustained a closed head injury, defined as externally inflicted trauma without skull fracture within the last month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific biomarkers (alone or in combination) assessed 3 months after MTBI
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/MTBI. This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
Measured: 3 months after MTBI.
Specific biomarkers (alone or in combination) assessed 6 months after MTBI.
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/MTBI. This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
Measured: 6 months after MTBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJun 2014
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vani Rao, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891941
- Sponsor's protocol ID
- NA_00078556
- Status last verified
- Sep 2016
- First submitted
- 19 Sep 2013
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02891941
- Acronym / sponsor ID
- NA_00078556
- Conditions
- Traumatic Brain Injury, Injury of Body Region
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Sep 2016 (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.
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/mild traumatic brain injury (MTBI).
Detailed description
This will be a prospective study of subjects with MTBI, body injury and healthy controls. Subjects who meet the study criteria will be enrolled in the study after they provide informed consent.
All subjects will be followed longitudinally at 3 and 6 months post-injury.
All subjects will have 3-4 visits:
Screening visit to determine eligibility; first study visit within 1 month of injury for those with brain or body injury (at the time of screening or within 1 month of screening for healthy controls); second study visit at 3 months post-injury (3 months after the first visit for healthy controls) and third study visit at 6 months post-injury (6 months after the first visit for healthy controls).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild Traumatic Brain Injury | – | –This cohort will have sustained a closed head injury, defined as externally inflicted trauma without skull fracture within the last month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency rooms, local physicians, free-standing urgent care establishments, local community
Key inclusion criteria (13 listed)
- Have sustained a closed head injury, defined as externally inflicted trauma without skull fracture;
- Have a Glasgow Coma Scale (GCS) score 13 or above
- Meet the American Congress of Rehabilitation Medicine criteria for mild traumatic brain injury
- Have experienced the last injury within 1 month
- Be in excellent/good medical health as assessed by the General Medical Health Rating (GMHR) scale
Key exclusion criteria (7 listed)
- History of stroke, seizures or other pre-injury neurological diseases
- Mental Retardation
- History of skull fracture
- Presence of severe unstable medical disease
- Contraindications to the MRI brain scan
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
Specific biomarkers (alone or in combination) assessed 3 months after MTBI
Time frame: 3 months after MTBI.
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/MTBI. This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
Specific biomarkers (alone or in combination) assessed 6 months after MTBI.
Time frame: 6 months after MTBI
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/MTBI. This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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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.
Vani Rao, MD principal investigator
Johns Hopkins University
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 Traumatic Brain Injury and Injury of Body Region, run by Johns Hopkins 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 13 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Sep 2016. 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 was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
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?
Specific biomarkers (alone or in combination) assessed 3 months after MTBI (time frame: 3 months after MTBI.). The study lists 2 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 8 Sep 2016.