NCT06934356 Subcortical Arousal in Perceptual Awareness
| NCT ID | NCT06934356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 202 participants in total. It began in 2025-10-13 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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 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.
Contact & Investigator
Hal Blumenfeld, MD, Phd
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06934356 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06934356 currently recruiting?
Yes, NCT06934356 is actively recruiting participants. Contact the research team at Hal.blumenfeld@yale.edu for enrollment information.
Where is the NCT06934356 trial being conducted?
This trial is being conducted at New Haven, United States, Kansas City, United States, Boston, United States, Rochester, United States and 4 additional locations.
Who is sponsoring the NCT06934356 clinical trial?
NCT06934356 is sponsored by Yale University. The principal investigator is Hal Blumenfeld, MD, Phd at Yale University. The trial plans to enroll 202 participants.
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