Shared Subcortical Arousal Systems Across Perceptual Modalities
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study is a multi-site study and will be conducted at up to 11 investigative sites in the United States. The study will investigate subcortical arousal circuits in visual perception using techniques with complementary strengths based on promising initial studies.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:
• normal vision with or without the use of corrective lenses
• normal vision with or without the use of corrective lenses
• 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.
Locations
United States
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
New Hampshire
Dartmouth Hitchcock Medical Center
NOT_YET_RECRUITING
Lebanon
Pennsylvania
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Hal Blumenfeld, MD, PHD
Hal.blumenfeld@yale.edu
(203) 785-3865
Backup
Kristine Dacosta
kristine.dacosta@yale.edu
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2030-12
Participants
Target number of participants: 72
Treatments
Experimental: Thalamic Recording (Aim 1)
Participants will perform the visual behavioral task with intracranial electroencephalogram (EEG) brain recordings carried out in parallel with surface EEG recordings. For Aim 1, we will analyze thalamic event related potentials in perceived vs not perceived stimuli, classified as in perception of no report visual stimuli based on eye metrics.
Experimental: Thalamic Stimulation (Aim 2)
We will test participants during the Visual Report Paradigm, while recording from the intralaminar thalamus with simultaneous scalp EEG as in Aim 1. Three thalamic stimulation conditions will be tested, randomized across trials: 1. No stimulation; 2. Stimulation Concurrent with visual stimuli; 3. Stimulation Delayed to 2s after visual stimuli. Stimulation will be a 100Hz train lasting 300ms, with biphasic square wave pulses 120μs per phase, current adjusted previously by clinicians to maximum tolerated level without side effects (typically \~3mA).~The electrical stimulation is being delivered for research purposes to understand the causal role of thalamus in regulating visual perception.
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)