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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
        • Contact:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Phone Number: TTY dial 711 (800) 411-1222
          • Email: ccopr@nih.gov
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Description

  • INCLUSION CRITERIA

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Stated interest in, and availability for, participating in NINDS studies and willingness to comply with the procedures of this protocol.
  2. At least 18 years of age.
  3. Ability to understand and willingness to sign a written informed consent document.
  4. 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:

  1. Major neurological or neurobehavioral disorder, such as seizure disorder, multiple sclerosis, major depression, or schizophrenia.
  2. Substance use disorder or illicit substance use.
  3. Deafness or blindness to a degree which would make participation in studies impossible, e.g., inability to communicate with investigators or read instructions.
  4. 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.
  5. Presence of implanted electronic devices, e.g., pacemakers, or other implanted object(s) making MRI unsafe or whose safety cannot be ascertained.
  6. Inability to tolerate MRI scanning for any reason.
  7. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From enrollment/consent until withdrawal from the registry or study closure.
From enrollment/consent until withdrawal from the registry or study closure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric M Wassermann, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 8, 2027

Primary Completion (Estimated)

January 8, 2035

Study Completion (Estimated)

January 8, 2035

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 8, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 10002262
  • 002262-N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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