How subcortical arousal affects perception
Shared Subcortical Arousal Systems Across Perceptual Modalities
NA · Yale University · NCT06934356
This study will test whether activity in deep arousal circuits changes how healthy adults and people with epilepsy (who have thalamic electrodes) perceive sights, sounds, and touch using fMRI, eye measurements, behavioral tests, and direct thalamic recordings and stimulation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 8 sites (New Haven, Connecticut and 7 other locations) |
| Trial ID | NCT06934356 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are adults with normal vision and hearing for the healthy cohort (age 18+), and adolescents or adults with epilepsy who already have clinically placed thalamic electrodes (age 13+) for the patient cohort.
Not a fit: People without normal vision or hearing for accurate eye metrics, pregnant individuals, those with nonremovable ferromagnetic implants (preventing MRI), or people without thalamic electrodes are unlikely to receive direct clinical benefit from participation.
Why it matters
Potential benefit: If successful, the work could improve understanding of how deep arousal circuits shape perception and point toward better monitoring or targeted interventions for perceptual problems in epilepsy.
How similar studies have performed: Prior fMRI work from this group (including Kronemer et al., 2022) showed robust subcortical signals linked to visual perception, but combining cross-modal fMRI, eye-metric machine-learning, and direct thalamic recording/stimulation across modalities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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; (2) normal hearing not needing an assistive hearing device. Exclusion: (1) requires hard contact lenses or glasses to maintain normal vision (prevents accurate pupil and eye gaze measurements); (2) unable to perform the perception task due to cognitive impairment 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) normal hearing not needing an assistive hearing device. Exclusion: (1) unable to perform the perception task due to cognitive impairment
Where this trial is running
New Haven, Connecticut and 7 other locations
- 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 (NOT_YET_RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (NOT_YET_RECRUITING)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (NOT_YET_RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- Baylor College of Medicine — Houston, Texas, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy