How subcortical arousal affects perception

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project combines fMRI, eye-tracking (pupil and gaze), behavioral tasks, and direct thalamic recording/stimulation to study how shared subcortical arousal systems influence visual, auditory, and tactile perception. Healthy adult participants will undergo fMRI and eye-metric testing across replicated sessions (auditory and tactile cohorts, N=65 each) and the team will use an existing visual dataset (N=65) for comparison. Analyses will compare brain and eye-metric signatures for perceived versus not-perceived stimuli and will apply machine-learning classification of eye metrics to identify report-independent markers of perception. A separate patient cohort with epilepsy and implanted thalamic electrodes will undergo direct recording and stimulation alongside eye and behavioral measures at participating epilepsy centers.

Why it matters

Who can join: the full rules

A. The following are the inclusion/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 it's running

• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Dartmouth Hitchcock Medical Center
  Lebanon, New Hampshire, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Hal Blumenfeld, MD, Phd — Yale University
• Study coordinator: Hal Blumenfeld, MD, PHD
• Email: Hal.blumenfeld@yale.edu
• Phone: (203) 785-3865

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.