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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eric M Wassermann, M.D.
- Número de teléfono: (301) 496-0151
- Correo electrónico: wassermanne@nih.gov
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center
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Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 (800) 411-1222
- Correo electrónico: ccopr@nih.gov
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Contacto:
- Eric Wassermann, M.D.
- Número de teléfono: 301-496-0151
- Correo electrónico: wassermanne@nih.gov
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Voluntarios sanos
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Eric M Wassermann, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 10002262
- 002262-N
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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