NCT03407066

Brief Summary

Background: When people see and hear, the brain changes signals from the eyes and ears into perceptions and thoughts. No one fully understands how this happens. Researchers want to explore how healthy brains process sights and sounds. Objectives: To explore how people understand what they see and hear when the brain processes sights and sounds. Eligibility: Participants aged 13-65 who have at least 20/40 vision in at least one eye and do not use a hearing aid. Design: Some participants will take tests online anonymously. They will do computer tasks related to colors and behavior. In-person participants will be screened with medical history and physical exam. They will complete questionnaires and vision and hearing tests. Participants will plan how many testing sessions they will have and when. Sessions last 2-5 hours. They may include:

  • Magnetic Resonance Imaging: Magnets and radio waves to take pictures of the brain. Participants will lie on a table that slides in and out of a tube. They will do a task during the scan.
  • Magnetoencephalography: Records magnetic field changes from brain activity. Participants will sit or lie down. A cone will be lowered onto their head. They may do a task during the test.
  • Electromyography: Electrodes attached to the skin will measure the electrical activity of muscles.
  • Electroencephalogram: Electrodes on the scalp will record brain waves.
  • Electrocardiography: Electrodes on the chest will record heart electrical activity.
  • Tests of memory, attention, thinking, vision, and hearing.
  • Eye Tracking: Cameras will follow participants eye movements. They may wear a cap with infrared cameras in front of their eyes. During the sessions, participants vital signs may be monitored.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Mar 2019Dec 2027

First Submitted

Initial submission to the registry

January 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 1, 2026

Status Verified

March 23, 2026

Enrollment Period

8.8 years

First QC Date

January 20, 2018

Last Update Submit

April 30, 2026

Conditions

Keywords

Magnetic Resonance Imaging (MRI)MEGColor VisionNeuroimagingNatural History

Outcome Measures

Primary Outcomes (3)

  • MRI

    We will analyze the anatomical structures of the brain (structural MRI or DTI); amplitude of the BOLD signal (fMRI).

    duration of the study

  • MEG

    We will quantify measures such as power spectrum, event- of task-related potentials, synchronization/de-synchronization and coherence between sensors or sources located close to the brain areas of interest.

    duration of the study

  • Behavioral Measures

    We will quantify measures such as hit rate, reaction times, detection thresholds, eye movement patterns, color, shape and sound judgement. We may measure autonomic data during the course of the sub-study (such as heart rate, respiration, end-tidal CO2, skin conductance), which will be correlated to the outcome measures.

    duration of the study

Study Arms (2)

In-person

200 in-person healthy volunteers

On-line

10,000 on-line healthy volunteers

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For in-lab testing, two hundred subjects (200) will be recruited from a healthy adult population and are expected to represent a broad cross-section of the population. For on-line testing, we anticipate up to 10,000 subjects will be recruited.

You may qualify if:

  • A subject can be included in the in-lab portion of the study if he/she:
  • is in good general health;
  • is between 18 and 65 years old;
  • has visual acuity of 20/40 in at least one eye (corrected with contact lenses is okay);
  • has no hearing impairment requiring a hearing aid.
  • is capable of understanding the procedures and requirements of this study;
  • is willing and able to provide his/her own informed consent.
  • A subject can be included in the on-line portion of the study if he/she:
  • is in good general health;
  • is between 18 and 65 years old;
  • is capable of understanding the procedures and requirements of this study;
  • is willing and able to provide his/her own informed consent.
  • A subject can be included in the off-site portion of the study if he/she:
  • is between 13 and 65 years old;
  • is in general good health;
  • +2 more criteria

You may not qualify if:

  • Participant is pregnant
  • Participant has serious vision or hearing problems; for some sub-studies focused on mechanisms of normal color vision, subjects who are colorblind will also be excluded;
  • Participants without consent capacity will not be enrolled;
  • Participant has a debilitating neurological disorder (examples include, but are not limited to: brain tumor, epilepsy, Alzheimer's Disease, Parkinson's Disease, multiple sclerosis) or a psychiatric disorder (examples include, but are not limited to: schizophrenia, clinical anxiety, severe depression, attention deficit hyperactivity disorder (ADHD), schizophrenia). Patients with non-debilitating conditions such as prosopagnosia, prosopometamorphosia (PMO), or aphantasia will have their conditions noted but will not be excluded);
  • Participant has had a serious head injury or has a history of brain surgery. Head injury is defined as an injury to the brain from some external force resulting in loss of consciousness of 30 minutes or more;
  • Participant is an NEI employee within the Perception, Cognition and Action section.
  • Contraindication to MR scanning include the following: metallic tattoos or metallic eyeliner; claustrophobia; inability to lie still on their back for approximately 2 hours; implanted cardiac pacemaker or auto-defibrillator; surgical aneurysm clips; implanted neural stimulator; artificial heart valves or pumps; metal fragments in cranial cavity, body or eyes (e.g., history as a metal worker); nitroglycerin patch (foil backer); cochlear implants (tubes are okay); weight \> 450 lbs; metal rods, plates, screws in body; shrapnel or bullet wound; intrauterine device (IUD) not approved on mrisafety.com (most IUDs are okay); vestibular or inner ear abnormality such as Meniere's disease; metallic braces; hair extensions attached with metallic wires; transdermal patches; movement disorders; dental implants; consumed of nicotine or caffeine in the two hours prior to the experimental session. Subjects may participate in this study but will not be allowed to have a 7.0 T MRI scan if they have metallic dental crowns or a bridge.
  • Off-site participation will be biased to participants with XY chromosomes until the genetic sequencing capability changes. We do not limit to just XY patients to provide the possibility of evaluating newer genetic sequencing capacity and because sequencing on XX can provide some information, even if it is not as decisive as on XY patients.
  • Subjects may not participate in the on-line portion of the study if they:
  • Do not have access to compatible equipment. For example, smartphone screens are too small to be used. The online platform will outline which devices may be used.
  • Are unwilling to allow permission for JavaScript to run on the site and disable any script blockers.
  • Are unwilling to agree to the on-line testing platform's terms and conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

Study Officials

  • Bevil R Conway, Ph.D.

    National Eye Institute (NEI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne F Duyck, Ph.D.

CONTACT

Bevil R Conway, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2018

First Posted

January 23, 2018

Study Start

March 26, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-03-23

Data Sharing

IPD Sharing
Will not share

Locations