Healthy Volunteer Recruitment and Characterization for NINDS Studies

Обзор

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.

Подробное описание

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

Первичные конечные точки

• 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. [Срок оценки: From enrollment/consent until withdrawal from the registry or study closure.]

Критерии участия

• 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))

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• National Institutes of Health Clinical Center — Bethesda

Идентификаторы

NCT: NCT07700511 · 10002262 · 002262-N

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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