Clinical trial NCT06934356: Subcortical Arousal in Perceptual Awareness
Official title: Shared Subcortical Arousal Systems Across Perceptual Modalities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2025-04-18
Enrollment: 72
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study will investigate subcortical arousal circuits in visual perception using techniques with complementary strengths based on promising initial studies. This study is expected to shed important light on the precise relationship between transient increases in subcortical arousal and perceptual awareness, generalizable across the visual modality. This research will therefore provide important general potential benefits, including 1. Identification of subcortical arousal systems in perception, which can benefit treatment of many disorders where perceptual deficits are common, e.g. traumatic brain injury, Alzheimer's disease, stroke, developmental disorders, schizophrenia, epilepsy and others. 2. Understanding the role of specific subcortical arousal circuits in perception may help target improved treatments, including transient thalamic stimulation like that planned for the present investigations, or less invasive treatments (TMS, tDCS, designer drugs) to improve function of these circuits. 3. The planned no-report paradigms may detect perceptual awareness in severe brain damage and anesthesia, where people are unable to overtly respond.

The main hypotheses are that 1. the thalamic awareness potential (TAP) will be associated with visual perception independent of report, and 2. thalamic intralaminar stimulation at the time of stimulus presentation will augment the probability of perceptual awareness.

Eligibility criteria: The following are the inclusion/exclusion criteria for epilepsy patients with thalamic electrodes age 13 years and up (Aim 1):

Inclusion Criteria:

* normal vision with or without the use of corrective lenses
* normal hearing not needing an assistive hearing device

Exclusion Criteria:

* severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements)
* unable to perform the perception task due to cognitive impairment other than due to the participant's epilepsy. All participants must be capable of consenting for themselves.

The following are the inclusion/exclusion criteria for epilepsy patients with thalamic electrodes age 18 years and up (Aim 2):

Inclusion Criteria:

* normal vision with or without the use of corrective lenses
* normal hearing not needing an assistive hearing device
* 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 Criteria:

* severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements)
* unable to perform the perception task due to cognitive impairment other than due to participant's epilepsy. All participants must be capable of consenting for themselves.
* pregnancy

Primary outcomes:
measure: Subcortical event-related signals
timeFrame: Immediately after the intervention
measure: Perceptual Sensitivity
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Cortical Event Related Potentials
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Yale University
name: Hal Blumenfeld, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: