Clinical trial NCT02891941: Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
Official title: Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Injury of Body Region
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency rooms, local physicians, free-standing urgent care establishments, local community

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).

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.

Primary outcomes:
measure: Specific biomarkers (alone or in combination) assessed 3 months after MTBI
timeFrame: 3 months after MTBI.
measure: Specific biomarkers (alone or in combination) assessed 6 months after MTBI.
timeFrame: 6 months after MTBI
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Vani Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: