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Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891941
Recruitment Status : Terminated (Funding withdrawn)
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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).

Condition or disease
Traumatic Brain Injury Injury of Body Region

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
whole blood, plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Emergency rooms, local physicians, free-standing urgent care establishments, local community
Criteria

Inclusion Criteria:

Individuals with MTBI: Inclusion Criteria:

  1. Have sustained a closed head injury, defined as externally inflicted trauma without skull fracture;
  2. Have a Glasgow Coma Scale (GCS) score 13 or above
  3. Meet the American Congress of Rehabilitation Medicine criteria for mild traumatic brain injury
  4. Have experienced the last injury within 1 month
  5. Be in excellent/good medical health as assessed by the General Medical Health Rating (GMHR) scale
  6. Have sufficient cognitive capacity to provide informed consent
  7. Be between 18-65 years of age and
  8. 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:

  1. No history of head injury or any other types of brain injury
  2. Inclusion criteria 5-8

Exclusion Criteria:

  1. History of stroke, seizures or other pre-injury neurological diseases
  2. Mental Retardation
  3. History of skull fracture
  4. Presence of severe unstable medical disease
  5. Contraindications to the MRI brain scan
  6. Possibility of pregnancy
  7. Presence of communication difficulties, such as moderate to severe hearing or language impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891941


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Vani Rao, MD Johns Hopkins University
Additional Information:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02891941    
Other Study ID Numbers: NA_00078556
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating