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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02891941
• Other study ID #: NA_00078556
• Status: Terminated
• Phase: N/A
• First received: September 19, 2013
• Last updated: September 1, 2016
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Injury of Body Region
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No