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Perception, Sensation, Cognition and Action in Humans

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ClinicalTrials.gov Identifier: NCT03407066
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

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:

Adults ages 18-65 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.


Condition or disease
Normal Physiology

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 10200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Perception, Sensation, Cognition and Action in Humans
Estimated Study Start Date : June 26, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
1
200 in-person participants and up to 10,000 on-line volunteers.



Primary Outcome Measures :
  1. In general, for behavioral experiments, reaction time and accuracy on a task will be the main measures. For fMRI experiments, BOLD percent signal change will be the primary outcome measure. [ Time Frame: Ongoing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal volunteer participants aged 18-65, who are in good general health and have normal or corrected-to-normal vision will be recruited from the local community and studied under this minimal risk protocol. Plan to recruit up to 200 in-person participants and up to 10,000 on-line volunteers.
Criteria
  • INCLUSION CRITERIA FOR ALL PARTICIPANTS:

A subject can be included in this 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;

ADDITIONAL INCLUSION CRITERIA FOR IN-LAB PARTICIPANTS:

  • 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.

EXCLUSION CRITIERA 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 has serious vision or hearing problems; for some sub-studies focused on color vision, subjects who are colorblind will also be excluded;
  • Participants without consent capacity will not be enrolled.
  • Participant has a neurological disorder (examples include, but are not limited to: epilepsy, schizophrenia, Alzheimer s Disease, Parkinson s Disease, multiple sclerosis)
  • 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 DSM V, 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 (Duncan and Northoff, 2013); Over-thecounter medication/herbals will not be a criterion for exclusion.
  • Participant is an NEI employee within the Sensation, Cognition and Action section.

ADDITIONAL EXCLUSION CRITERIA FOR MRI SUB-STUDIES:

Contraindication to MR scanning include the following: pregnancy; metallic tattoos or metallic eyeliner; claustrophobia; inability to lie still on their back for ~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 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. Amazon MTurk 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 Amazon MTurk's terms and conditions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407066


Contacts
Contact: Allison T Bamji, R.N. (301) 451-3437 bamjia@nei.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Principal Investigator: Bevil Conway, Ph.D. National Eye Institute (NEI)