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

Stopped early

Conditions studied: Traumatic Brain Injury, Injury of Body Region

In brief

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).

Key facts

Study ID

NCT02891941

Run by

Johns Hopkins University

People needed

10

Starts

2013-06-01

Expected to finish

2014-06-01

Last updated by the study team

2016-09-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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