Subcortical Arousal in Perceptual Awareness
Recruiting · NCT06934356 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Behavioral taskEEGEye TrackingfMRI
What this trial is about
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.
Who can take part
Age range
13 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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 is running
8 locations listed across 8 US states.
- Yale School of Medicine - New Haven, Connecticut, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire, United States
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Baylor College of Medicine - Houston, Texas, United States