Modulation of Emotion Perception in Humans Via Amygdala Stimulation

NCT ID: NCT05292183

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-02-16

Brief Summary

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.

Detailed Description

One to two study tasks will be performed by each participant to help us understand how the brain processes emotion and how stimulation effects emotional processing.

These study tasks will last up to several minutes each, and generally require participants to view pictures while EEG recordings are made from the electrodes placed in specific areas of the brain. The routine video/EEG monitoring and brain function testing should not be disrupted or prolonged by the study testing, and if a participant has a seizure during the testing, it will be recorded as usual for review by participant's providers.

The following study procedures will likely be carried out in each individual case:

1. Recording from areas important in social and emotional processing.

A computer monitor will be used to present pictures of people engaged in social interaction. Additionally, the researchers will present individual participants with well standardized tasks designed to understand the nature of emotions. Some of these images may be emotionally disturbing. Should participants become uncomfortable with viewing such images, participants would be provided with a choice to not participate in this study.

2. Using brain stimulation to map function of certain parts of your brain.

A brain stimulator will be used -normally used to map where important brain regions are located-to understand new functions of the brain. Each participant will be presented with pictures on a computer screen. As participant(s) views these pictures, the brain stimulator may be activated (this is not something that is felt by a person) and an electrical stimulation through the implanted electrodes will be delivered to specific regions of the brain. Research team will be measuring how brain stimulation may affect each individual's emotional response to a specific stimulus.

3. Completing the Emotion Self-Rating (ESR) Scale.

This questionnaire will be given to ensure the stimulation doesn't increase any unpleasant emotional experience for participants. This will take place before and during the stimulation of a specific part of the brain.

Conditions

Refractory Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Stimulation

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 Type: EXPERIMENTAL

Electrical Stimulation

Intervention Type: OTHER

We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures.

No stimulation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Electrical Stimulation

We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age of 18 years or older
• FSIQ 75 and above or any equivalent test of generalized intelligence as determined by the PI to adequately predict engagement in the task
• Able to give independent consent for participation in the study

Exclusion Criteria

• Additional neurological disorders (such as dementia, stroke, brain tumor, etc.)
• 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.
• Anything else, that in the opinion of the principal investigator, might preclude them from participating in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Krzysztof Bujarski

Section Chief, Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krzysztof A Bujarski, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21MH124674-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY02001399

Identifier Type: -

Identifier Source: org_study_id