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

Johns Hopkins University

Status: Terminated

Conditions: Traumatic Brain Injury; Injury of Body Region

Study type: Observational

Funder types: Other

Identifiers

NCT02891941

NA_00078556

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Mild Traumatic Brain Injury

Description:

This cohort will have sustained a closed head injury, defined as externally inflicted trauma without skull fracture within the last month.