Amygdala Stimulation for Epilepsy

Recruiting in Palo Alto (17 mi)

Overseen byKrzysztof A Bujarski, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dartmouth-Hitchcock Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have intracranial EEG electrodes. In this study, the aim is to record brain signals from areas important in social and emotional processing and to understand how electrical brain stimulation - called neuromodulation - affects such processing. Patients enrolled in this study will be asked to view images depicting a variety of emotionally positive, negative, or neutral themes. As the patient views these images, a small amount of imperceptible and painless electric current will be used to map function of certain parts of a human brain. The overarching goal of the study is to determine if neuromodulation can be used in certain areas of the brain to treat cognitive disorders such as memory loss and post-traumatic stress disorder.

Research Team

Krzysztof A Bujarski, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 18 with epilepsy who are being evaluated for surgery and can consent to participate. They must have normal intelligence levels and be able to engage in the study tasks. People with psychiatric conditions affecting consent or task performance, or other neurological disorders like dementia, stroke, or brain tumors cannot join.

Inclusion Criteria

I am 18 years old or older.

I can make my own decisions about joining this study.

You have a certain level of intelligence as determined by a test given by the study leader.

Exclusion Criteria

Any psychiatric condition that would limit their ability to provide consent and/or perform study tasks within normal limits. This would be based on presurgical psychiatric assessment.

I have no other neurological disorders like dementia or stroke.

Anything else, that in the opinion of the principal investigator, might preclude them from participating in the study

Treatment Details

Interventions

Electrical Stimulation (Electrical Stimulation)

Trial OverviewThe study tests how electrical stimulation (neuromodulation) of the brain affects emotion perception in epilepsy patients undergoing surgical evaluation. Participants will view emotional images while receiving imperceptible electric currents to map brain function related to social and emotional processing.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: StimulationExperimental Treatment1 Intervention

This part will include 24 randomly chosen images from each of four categories (total of 96 images varying in valence and arousal) and will be presented block-randomized amygdala stimulation.

Group II: No stimulationActive Control1 Intervention

This part will include 24 randomly chosen images from each of four categories (total of 96 images varying in valence and arousal) and will be presented without amygdala stimulation.

Electrical Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Electrical Stimulation for: