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

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).

Study Overview

• Status: Terminated
• Conditions: 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).

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Emergency rooms, local physicians, free-standing urgent care establishments, local community

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months after MTBI

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Vani Rao, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: NA_00078556