Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury
Imaging Biomarkers of Delayed Sequelae in Mild to Moderate Traumatic Brain Injury
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Illinois
-
Evanston, Illinois, 미국, 60201
- Northshore University Healthsystem
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
DaTSCAN
기간: At least one year post ER visit for mTBI or mTBI-
|
We will perform qualitative (visual) and quantitative (DaTQUANT) analyses of striatal uptake.
|
At least one year post ER visit for mTBI or mTBI-
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
clinical assessment
기간: 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).
|
At least one year post ER visit for mTBI or mTBI-
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Demetrius M Maraganore, MD, Northshore University Healthsystem
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .