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Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

Subcortical Arousal Study for Epilepsy

Recruiting at 7 trial locations

Overseen ByKristine Dacosta

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Severe vision impairment, Cognitive impairment, Pregnancy

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Behavioral task, EEG, Eye Tracking for epilepsy?

Research suggests that stimulating subcortical arousal networks can improve consciousness during seizures, which is a key issue in epilepsy. This approach has shown promise in animal models, indicating that targeting these brain areas might help improve arousal and consciousness in people with epilepsy.¹ ² ³ ⁴ ⁵

Is the subcortical arousal treatment safe for humans?

Research suggests that stimulating certain brain areas can improve alertness and reduce seizures in epilepsy, and this approach may be compatible with existing devices used for brain stimulation. While specific safety data for humans is limited, the treatment has shown promise in animal studies and may benefit people with epilepsy and other consciousness disorders.¹ ⁴ ⁵ ⁶ ⁷

How does the Behavioral task treatment for epilepsy differ from other treatments?

The Behavioral task treatment for epilepsy is unique because it focuses on stimulating subcortical arousal structures, like the thalamus, to restore consciousness during seizures. This approach is different from traditional treatments as it targets the brain's arousal networks to improve awareness and behavior, especially in cases where other medical and surgical therapies have failed.¹ ⁴ ⁵ ⁷ ⁸

What is the purpose of this trial?

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.

Research Team

Hal Blumenfeld, MD, Phd

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with normal vision and hearing, including those with epilepsy who have thalamic electrodes. Participants must be aged 13 or older, capable of consenting, not pregnant, using reliable birth control if applicable, and able to perform perception tasks without cognitive impairments unrelated to epilepsy.

Inclusion Criteria

Normal vision with or without the use of corrective lenses

Normal hearing not needing an assistive hearing device

Normal vision with or without the use of corrective lenses

See 4 more

Exclusion Criteria

Severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements)

Pregnancy

I am 13 or older with epilepsy and have thalamic electrodes.

See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Thalamic Recording (Aim 1)

Participants perform the visual behavioral task with intracranial EEG brain recordings and surface EEG recordings to analyze thalamic event-related potentials.

4 weeks

Multiple visits for EEG recordings

Thalamic Stimulation (Aim 2)

Participants are tested during the Visual Report Paradigm with thalamic stimulation conditions randomized across trials.

4 weeks

Multiple visits for stimulation sessions

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

Behavioral task
EEG
Eye Tracking

Trial Overview The study examines how subcortical arousal circuits affect visual perception in people with epilepsy. It uses EEGs for brain activity monitoring, eye tracking to follow gaze and pupil changes, and behavioral tasks to assess awareness. Conducted across multiple U.S. sites, it builds on initial promising results.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Thalamic Stimulation (Aim 2)Experimental Treatment3 Interventions

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.

Group II: Thalamic Recording (Aim 1)Experimental Treatment3 Interventions

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.