Healthy Volunteer Recruitment and Characterization for NINDS Studies
Background:
The National Institute of Neurological Disorders and Stroke (NINDS) often enrolls healthy volunteers in certain studies. These studies allow researchers to look for causes of diseases and disorders by comparing affected people to healthy ones. Prescreening lets volunteers participate in multiple studies without having to repeat the screening tests each time. Having a registry of prescreened volunteers also makes it easier for researchers to reach people willing to participate in their studies.
Objective:
To create a registry of healthy volunteers who have been prescreened for NINDS research studies.
Eligibility:
Healthy people aged 18 years and older.
Design:
Participants will have 1 clinic visit for prescreening. This visit will take about 5 hours. The visit may be spread across 1 to 3 days.
Participants will have the following procedures:
A physical exam, including height, weight, and vital signs.
A review of their medical history and medications. They will also provide personal data such as age, sex, and years of education.
An exam of their nervous system. This will include tests of their strength and reflexes, following an object with their eyes, and other tasks.
Cognitive tests. These tests will check their memory, attention, and thinking.
A magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a cylinder; Magnetic fields will create images of their brain.
Handedness. They will complete a questionnaire about what hand they use for most tasks.
Participants may remain on the healthy volunteers list for 2 years. If they wish to participate longer, they will need to return to repeat all of the screening tests.
연구 개요
상태
정황
상세 설명
Study Description:
This protocol will create a registry of healthy volunteers for intramural NINDS. It will provide a vehicle for recruiting, examination, and preliminary testing of healthy research volunteers for NINDS studies. We plan to retain data for use in future research by creating a repository.
Objectives:
To provide a centralized and standardized service for recruiting, screening, and characterizing healthy volunteers by creating a repository for secondary research
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Eric M Wassermann, M.D.
- 전화번호: (301) 496-0151
- 이메일: wassermanne@nih.gov
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center
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연락하다:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- 전화번호: TTY dial 711 (800) 411-1222
- 이메일: ccopr@nih.gov
-
연락하다:
- Eric Wassermann, M.D.
- 전화번호: 301-496-0151
- 이메일: wassermanne@nih.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
- INCLUSION CRITERIA
To be eligible to participate in this study, an individual must meet all the following criteria:
- Stated interest in, and availability for, participating in NINDS studies and willingness to comply with the procedures of this protocol.
- At least 18 years of age.
- Ability to understand and willingness to sign a written informed consent document.
- Fluent in English, or another language that allows the use of a validated MoCA or MoCA Duo to be completed (see the following list of languages Paper (mocacognition.com) or Digital tools (mocacognition.com))
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
- Major neurological or neurobehavioral disorder, such as seizure disorder, multiple sclerosis, major depression, or schizophrenia.
- Substance use disorder or illicit substance use.
- Deafness or blindness to a degree which would make participation in studies impossible, e.g., inability to communicate with investigators or read instructions.
- Identified major health concerns (e.g., uncontrolled diabetes mellitus, congestive heart failure, liver cirrhosis, malignancy requiring ongoing cytotoxic chemotherapy, immunotherapy, or radiation) as evidenced by screening medical history.
- Presence of implanted electronic devices, e.g., pacemakers, or other implanted object(s) making MRI unsafe or whose safety cannot be ascertained.
- Inability to tolerate MRI scanning for any reason.
- Pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
건강한 자원봉사자
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To screen and create a temporary list of volunteers in good health for participation in NINDS studies (Volunteer List) in order to reduce costs, inconvenience to volunteers, and duplication of effort.
기간: From enrollment/consent until withdrawal from the registry or study closure.
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From enrollment/consent until withdrawal from the registry or study closure.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eric M Wassermann, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 10002262
- 002262-N
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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