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.
調査の概要
状態
条件
詳細な説明
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
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Eric M Wassermann, M.D.
- 電話番号：(301) 496-0151
- メール：wassermanne@nih.gov
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center
-
コンタクト：
- NIH Clinical Center Office of Patient Recruitment (OPR)
- 電話番号：TTY dial 711 (800) 411-1222
- メール：ccopr@nih.gov
-
コンタクト：
- Eric Wassermann, M.D.
- 電話番号：301-496-0151
- メール：wassermanne@nih.gov
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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健康なボランティア
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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.
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Eric M Wassermann, M.D.、National Institute of Neurological Disorders and Stroke (NINDS)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 10002262
- 002262-N
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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