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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Recruitment Status : Terminated (Funding withdrawn)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

Tracking Information
First Submitted Date September 19, 2013
First Posted Date September 8, 2016
Last Update Posted Date September 8, 2016
Study Start Date June 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2016)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
Official Title Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
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).
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples With DNA
Description:
whole blood, plasma
Sampling Method Non-Probability Sample
Study Population Emergency rooms, local physicians, free-standing urgent care establishments, local community
Condition
  • Traumatic Brain Injury
  • Injury of Body Region
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 1, 2016)
10
Original Actual Enrollment Same as current
Actual Study Completion Date June 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02891941
Other Study ID Numbers NA_00078556
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Vani Rao, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2016