Modulation of Emotion Perception in Humans Via Amygdala Stimulation

NCT05292183 | Completed Results DMC

• 2 other identifiers: STUDY020013991R21MH124674-01A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy

Keywords

Human Amygdala; Deep Brain Stimulation; Psychiatric Disorders

Outcome Measures

Primary Outcomes (2)

• Z-score Gamma Power in Amygdala Per Valence Category

  Valence of each image is assessed by each subject using a Likert-type rating scale with a range of 1 to 7, where 1 represents most negative valence, 4 as neutral, and 7 as most positive. Valence categories are defined in the following manner: negative = 1.0 to 3.0, neutral = 3.1 to 5.0, negative = 5.1 to 7.0. Activation is measured by gamma frequency power (mµV²/30-100 Hz) at 0-1000 msec following image presentation in the basolateral amygdala electrode contact and compared to baseline defined as -500 msec to 0 of image presentation. Gamma power is transformed to z-score (baseline to following image presentation) for individual observations. Z-score of 0 indicates no change from baseline. Positive z-score indicates activation of the basolateral amygdala compared to baseline. Gamma frequency range is defined as 30-100 Hz in intracranial EEG. Power was estimated via a multitaper time-frequency transformation approach. Statistics was done using linear-mixed effects models (LMEs).

  0 to 1000 MS following image presentation

• Effect of Amygdala Stimulation on Perception of Valence

  Here we assess the effect of basolateral amygdala stimulation on valence ratings. Participants rate the emotional valence of each image in a Likert scale range of 1-7 (1= maximum negative valence, 4=maximum neutral valence, and 7 maximum positive valence) for each of the 96 images. We randomly apply electrical stimulation during perception and of 50% of the images presented. We analyze the effect of stimulation on image rating in the following manner: we grouped the images into three categories, negative (1 to 3), neutral (3.1 to 5), and positive (5.1 to 7) based on subject specific ratings. 2. We then used a multivariate model to assess the effect of stimulation on perception of neutral, negative, and positive categories across 9 patients.

  Valence ratings were assessed immediately following the viewing of each image during performance of the task.

Study Arms (2)

Stimulation

EXPERIMENTAL

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.

Other: Electrical Stimulation

No stimulation

NO 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.

Interventions

Electrical Stimulation OTHER

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

Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03776, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Mental Disorders

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: Dr. Krzysztof Bujarski
• Organization: Dartmouth-Hitchcock Medical Center

krzysztof.a.bujarski@hitchcock.org

603 650 5104

Study Officials

• Krzysztof A Bujarski, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Neurology

Model Details: The researchers will use computerized randomization of electrical stimulation for each participant. The stimulation vs non stimulation are not discrete events and occur in random order within individual participants during each daily testing session.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: March 31, 2022
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)