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

NCT ID: NCT02891941

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

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).

Conditions

Traumatic Brain Injury; Injury of Body Region

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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,

1. No history of head injury or any other types of brain injury

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vani Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00078556

Identifier Type: -

Identifier Source: org_study_id