NCT03407066 Perception, Sensation, Cognition and Action in Humans
| NCT ID | NCT03407066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Eye Institute (NEI) |
| Condition | Normal Physiology |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,200 participants |
| Start Date | 2019-03-26 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,200 participants in total. It began in 2019-03-26 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Off-site participants will be screened with questionnaires about themselves and their vision. If results indicate abnormal color vision, these off-site participants may be asked to provide saliva samples for genetic screening. In-person 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. ...
Eligibility Criteria
* INCLUSION CRITERIA: Inclusion Criteria for In-lab Participants 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. Inclusion Criteria for On-line Participants 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. Inclusion Criteria for Genetic Screening/Off-site Participants 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; * is capable of understanding the procedures and requirements of this study; * is willing and able to provide his/her own informed consent. EXCLUSION CRITERIA: Exclusion Criteria for In-lab Participants A participant is not eligible for participation in the in-lab portion of this study if any of the following exclusion criteria are present, as self-reported by the prospective participant or determined during clinical testing following consent: * 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 has psychoactive drug or alcohol abuse or dependence in the past three months, as determined by the Drug Abuse Screening Test (DAST), except nicotine and caffeine. A score of 6 or greater on the DAST will be considered exclusionary. The effects of nicotine and caffeine in neuroimaging are attenuated if participants do not smoke or consume caffeine 2-3 hours before the scan session; Over-the-counter medication/herbals will not be a criterion for exclusion; * Participant is an NEI employee within the Perception, Cognition and Action section. Additional Exclusion Criteria for MRI Sub-studies 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. Exclusion Criteria for Genetic Screening/Off-site Participants 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. Exclusion Criteria for On-line Participants 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 & Investigator
Bevil R Conway, Ph.D.
PRINCIPAL INVESTIGATOR
National Eye Institute (NEI)
Frequently Asked Questions
Who can join the NCT03407066 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 65 Years, studying Normal Physiology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03407066 currently recruiting?
Yes, NCT03407066 is actively recruiting participants. Contact the research team at nancy.chen@nih.gov for enrollment information.
Where is the NCT03407066 trial being conducted?
This trial is being conducted at Bethesda, United States, Bethesda, United States.
Who is sponsoring the NCT03407066 clinical trial?
NCT03407066 is sponsored by National Eye Institute (NEI). The principal investigator is Bevil R Conway, Ph.D. at National Eye Institute (NEI). The trial plans to enroll 10,200 participants.