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NCT Number: NCT01516281

Imaging Biomarkers of Delayed Sequelae in Trauma 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 (mTBI- or "controls").

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Key information

Conditions

Traumatic Brain Injury Basal Ganglia Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Synucleinopathies Trauma, Nervous System Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mTBI or mTBI- survey respondents
  • Ages 18-100 years
  • 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

Treatment and study plan

Primary outcomes

  1. DaTSCAN

    Time frame: At least one year post ER visit for mTBI or mTBI-

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

Secondary outcomes

  1. clinical assessment

    Time frame: At least one year post ER visit for mTBI or mTBI-

    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).

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

Imaging Biomarkers of Delayed Sequelae in Mild to Moderate Traumatic Brain Injury

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 24, 2012
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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