Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Demetrius M. Maraganore, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01516281
First received: January 19, 2012
Last updated: April 28, 2013
Last verified: April 2013

January 19, 2012
April 28, 2013
March 2012
December 2014   (final data collection date for primary outcome measure)
DaTSCAN [ Time Frame: At least one year post ER visit for mTBI or mTBI- ] [ Designated as safety issue: Yes ]
We will perform qualitative (visual) and quantitative (DaTQUANT) analyses of striatal uptake.
DaTSCAN [ Time Frame: one year post ER visit for mTBI or mTBI- ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01516281 on ClinicalTrials.gov Archive Site
clinical assessment [ Time Frame: At least one year post ER visit for mTBI or mTBI- ] [ Designated as safety issue: No ]
All subjects complete a questionnaire that documents lifelong exposures to mTBI; that screens for parkinsonism, Parkinson's disease, or tremor; and that screens for DaTSCAN exclusion criteria. We abstract medical records. Subjects eligible for DaTSCAN undergo the Montreal Cognitive Assessment (MoCA); Ohio State University TBI Identification Method Short Form (OSU-TBI-ID-SF); General Anxiety Disorder 7-item Scale (GAD7); Center for Epidemiological Studies Depression Scale (CES-D); Rivermead Post Concussion Symptoms Questionnaire; Insomnia Severity Index (ISI); World Health Organization Quality of Life-Brief Assessment (WHOQOL-BREF); Review of Systems; Past Medical History; Detailed Examination of Motor Function-Unified Parkinson's Disease Rating Scale (UPDRS part III); Neurological Examination; Syndromic Classification (parkinsonism, essential tremor, mild cognitive impairment); Differential Diagnosis of Parkinsonism (if applicable); Final Diagnosis of Parkinsonism (if applicable).
clinical assessment [ Time Frame: one year post ER visit for mTBI or mTBI- ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury
Imaging Biomarkers of Delayed Sequelae in Mild to Moderate Traumatic Brain Injury

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 (mTBA- or "controls").

This study is being done to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain ("biomarkers") that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a potential link between mild to moderate traumatic brain injury (mTBI) and PD. We will compare findings from persons who experienced mTBI ("cases") to persons without history of brain injury (mTBI-or "controls"). This study may provide preliminary data that might be used to help design future long-term studies.

The investigators propose scientific studies with one specific aim and two hypotheses:

Specific aim: to determine if one year post emergency room (ER) visits, DaTscan uptake (Ioflupane I123 injection and single photon emission computerized tomography) is lower in subjects exposed to mTBI (defined as a closed head trauma that results in loss of consciousness or amnesia for less than 24 hours) than in subjects not exposed to mTBI (without closed head trauma; mTBI-).

Hypotheses:

Hypothesis #1: mTBI is a risk factor for Parkinson's disease (PD). Hypothesis #2: DaTscan is able to detect subclinical PD (as measured by a dopamine transporter deficiency) in mTBI subjects.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

  • Traumatic Brain Injury
  • Parkinson's Disease
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • History of parkinsonism or tremor
  • Lugol or iodide allergy
  • Contraindicated medications for DaTscan
  • Pregnancy or nursing mothers
  • Renal or liver impairment
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516281
11-DAT-008
No
Demetrius M. Maraganore, MD, NorthShore University HealthSystem Research Institute
NorthShore University HealthSystem Research Institute
GE Healthcare
Principal Investigator: Demetrius M Maraganore, MD NorthShore University HealthSystem
NorthShore University HealthSystem Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP