跳至主要内容
临床试验/NCT03407066
NCT03407066招募中不适用

Perception, Sensation, Cognition and Action in Humans

National Eye Institute (NEI)2 个研究点 分布在 1 个国家目标入组 10,200 人开始时间: 2019年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,200
试验地点
2
主要终点
Behavioral Measures

研究概览

简要总结

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.

...

详细描述

Objective:

The experiments covered by this protocol aim to uncover basic knowledge about the brain mechanisms that give rise to perception and cognition. The protocol encompasses sub-studies in volunteers ("participants") to uncover behaviors and their physiological basis. The protocol includes only non- or minimally invasive techniques with minimal risk, including psychophysics, functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG), genetic sequencing, and on-line tests using web-based platforms. The overarching goal of the research is to obtain new knowledge in the organization and operation of cortical circuits involved in visual and auditory perception. The protocol covers six specific inter-related aims, with specific sub-studies:

  1. Neurophysiological Mechanisms for Color
  2. Object-Color Associations (Color Memory)
  3. Connectivity of Functionally-Defined Regions
  4. Homologies between Monkeys and Humans
  5. Functional Organization of Sound Perception and Visual-Auditory Integration
  6. Multi-stability in Color Perception

Study Population:

In-lab or on-line 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. We plan to recruit up to 100 in-person participants, 100 off-site participants, and up to 10,000 on-line volunteers. For off-site participants, the eligibility criteria will be ages 13-65. A subset of approximately 12 participants who are eligible and interested will be referred to this study (to the off-site cohort) from the Investigating Visual Recognition in Normal Populations and in Individuals with Recognition Impairment study at Dartmouth College (STUDY00022345).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Off-site

100 off-site healthy volunteers

On-line

10,000 on-line healthy volunteers

In-person

100 in-person healthy volunteers

结局指标

主要结局

Behavioral Measures

时间窗: duration of the study

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.

MEG

时间窗: duration of the study

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.

MRI

时间窗: duration of the study

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

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Perception, Sensation, Cognition and Action in Humans | 临床试验