Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2012 | ||||
| Last Updated Date | April 28, 2013 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
DaTSCAN [ Time Frame: one year post ER visit for mTBI or mTBI- ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01516281 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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). |
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| Original Secondary Outcome Measures ICMJE |
clinical assessment [ Time Frame: one year post ER visit for mTBI or mTBI- ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury | ||||
| Official Title ICMJE | Imaging Biomarkers of Delayed Sequelae in Mild to Moderate Traumatic Brain Injury | ||||
| 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 (mTBA- or "controls"). |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | 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. |
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| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01516281 | ||||
| Other Study ID Numbers ICMJE | 11-DAT-008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Demetrius M. Maraganore, MD, NorthShore University HealthSystem Research Institute | ||||
| Study Sponsor ICMJE | NorthShore University HealthSystem Research Institute | ||||
| Collaborators ICMJE | GE Healthcare | ||||
| Investigators ICMJE |
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| Information Provided By | NorthShore University HealthSystem Research Institute | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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