Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury

NCT01516281 | Completed

• 1 other identifier: EH11-345
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a possible association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122 subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University HealthSystem during the years 2006-2011, and to select from willing eligible subjects a random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to undergo written informed consent, neurological examinations, blood drawing for DNA extraction and storage, and DaTscan brain imaging. The investigators will compare the findings from persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or "controls").

Conditions

Traumatic Brain Injury; Parkinson's Disease

Keywords

TBI; PD

Outcome Measures

Primary Outcomes (1)

• DaTSCAN

  We will perform qualitative (visual) and quantitative (DaTQUANT) analyses of striatal uptake.

  At least one year post ER visit for mTBI or mTBI-

Secondary Outcomes (1)

• clinical assessment

  At least one year post ER visit for mTBI or mTBI-

Study Arms (2)

mTBI

Historical cohort of subjects seen in the emergency rooms of NorthShore University HealthSystem with ICD-9 diagnoses of mild or moderate traumatic brain injury during the years 2006-2011 (7,122 subjects). 100 mTBI+ subjects are randomly selected for clinical assessment and DaTscan.

mTBI-

Historical cohort of subjects seen in the emergency rooms of NorthShore University HealthSystem with ICD-9 diagnoses of disorders other than mild or moderate traumatic brain injury during the years 2006-2011 (7,122 subjects). 100 mTBI- subjects are randomly selected for clinical assessment and DaTscan.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A historical cohort of 7,122 mTBI cases and 7,122 age and gender matched mTBI- controls was defined from the electronic medical records of NorthShore University HealthSystem. From survey respondents we are randomly selecting 100 mTBI cases and 100 age and gender matched mTBI- controls to undergo neurological examinations and DaTscan studies.

You may qualify if:

• mTBI or mTBI- survey respondents
• Ages 18-100 years
• Without a history of parkinsonism or tremor

You may not qualify if:

• History of parkinsonism or tremor
• Lugol or iodide allergy
• Contraindicated medications for DaTscan
• Pregnancy or nursing mothers
• Renal or liver impairment

Sponsors & Collaborators

• Endeavor Health: lead
• GE Healthcare: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collect blood and extract and store plasma and DNA from 100 mTBI and 100 mTBI- subjects undergoing clinical assessments and DaTscan studies.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Parkinson Disease

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Demetrius M Maraganore, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 23, 2019

Record last verified: 2016-01

Locations

US (1)