NCT06934356 · Yale University
Subcortical Arousal in Perceptual Awareness
What this study is about
The study consists of forward-looking enrollment of healthy participants and patients with epilepsy, as well as analysis of an existing data set. Healthy participants will be studied with fMRI, eye metrics and behavioral testing at Yale. Patients will be studied with intracranial thalamic and cortical recording and stimulation, eye metrics and behavioral testing.
View original scientific description
The study consists of prospective enrollment of healthy participants and patients with epilepsy, as well as analysis of an existing data set. Healthy participants will be studied with fMRI, eye metrics and behavioral testing at Yale. Patients will be studied with intracranial thalamic and cortical recording and stimulation, eye metrics and behavioral testing.
Interventions
DEVICE
EEG
Participants will have scalp EEG recorded with the international 10-20 system sampled at 256Hz using EEG amplifiers for purposes of surface event related potential analysis
DEVICE
Eye Tracking
An eye-tracking device may be used during the perceptual awareness task. Pupillary and gaze location measurements are recorded using either a ViewPoint\~VoltagePro.EyeLink 1000 Plus system, or Argus Science ETVision system. If using the ViewPoint\~VoltagePro system or the Argus Science ETVision system, participants will be asked to wear an eye tracker during the perceptual awareness task (similar to wearing sunglasses). If using the EyeLink 1000 Plus system, participants may be asked to place their head inside of a padded head-chin rest to stabilize head position
DEVICE
Behavioral task
For the visual perceptual awareness task, the participant will be presented with barely perceptible visual stimuli. After a variable delay, the participant will be asked to report perception of each stimulus and identify its location.
DIAGNOSTIC_TEST
fMRI
Visual, auditory or tactile behavioral task will be performed during fMRI at the Yale MR Center. The subject will be asked to lie still in a 3T magnet scanner for up to 15-minute blocks. Each subject will have a sagittal T1-weighted localizer scan (3 minutes) and axial-oblique T1-weighted images (3 min). Multiple 5-15-minute imaging runs will be repeated up to 10 times. The subjects' responses will be recorded by a computer that is linked to the button box. The stimuli will be presented in blocks of 5 to 15 minutes throughout the MR imaging sequences.
Primary outcome measures
Subcortical event-related signals
Time frame: Immediately after the intervention
Subcortical event-related signals will be recorded by icEEG to assess electrical activity from the cerebral cortex using currently implanted electrodes during the behavioral task
Perceptual Sensitivity
Time frame: Immediately after the intervention
measured by the percentage of correctly perceived trials for each participant (Aim 3B)
Activity changes
Time frame: Immediately after the intervention
Measured using functional magnetic resonance imaging (fMRI) during task onset and off-set to fixation and compare them to fMRI changes during conscious perception of a stimulus vs. not-reported stimuli (Aims 1 and 2)
Functional connectivity
Time frame: Immediately after the intervention
Measured using fMRI to establish networks actively engaged during task vs. fixation and consciously-reported vs. not-reported stimuli (Aims 1 and 2).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Exclusion criteria
- for healthy participants age 18 years and up (Aim 1 and 2): Inclusion: (1) normal vision with or without the use of corrective lenses; (2) normal hearing not needing an assistive hearing device. Exclusion: (1) past history of diagnosis of a psychiatric or neurologic disease; (2) current psychiatric or neurologic disease; (3) requires hard contact lenses or glasses to maintain normal vision (prevents accurate pupil and eye gaze measurements); (4) pregnant or nonremovable ferrous metal objects inside or on the body (prevents MRI). B. The following are the inclusion/exclusion criteria for epilepsy patients with thalamic electrodes age 13 years and up (Aim 3A): Inclusion: (1) normal vision with or without the use of corrective lenses Exclusion: (1) severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements); (2) unable to perform the perception task due to cognitive impairment. All participants must be capable of consenting for themselves. C. The following are the inclusion/exclusion criteria for epilepsy patients with thalamic electrodes age 18 year and up (Aim 3B): Inclusion: (1) normal vision with or without the use of corrective lenses; (2) A female subject must have a negative pregnancy test and if sexually active, must be using a reliable form of birth control for the duration of the trial, be surgically sterile, or be at least two years post-menopausal. Exclusion: (1) severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements); (2) unable to perform the perception task due to cognitive impairment. All participants must be capable of consenting for themselves; (3) Pregnancy.
Where
- New Haven, Connecticut
- Kansas City, Kansas
- Boston, Massachusetts
- Rochester, Minnesota
- Lebanon, New Hampshire
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations