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Modulation of Emotion Perception in Humans Via Amygdala Stimulation

Primary Purpose

Refractory Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Stimulation
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Refractory Epilepsy focused on measuring Human Amygdala, Deep Brain Stimulation, Psychiatric Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 18 years or older
  • Full-scale IQ above 75, as determined by neuropsychological testing obtained prior to intracranial EEG
  • 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

Sites / Locations

  • Dartmouth-Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stimulation

No stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Better understand neural circuits responsible for processing valence as measured by the power in the gamma band in the valence circuit
Intracranial electroencephalogram (EEG) oscillatory rhythms from the valence circuit, including the amygdala and, as available, the anterior insula, the dorsal anterior cingulate, and ventromedial prefrontal lobe will be measured during performance of the Affective Valence Perception Task.
Better understand the neural circuits responsible for processing valence by measuring negative and positive valence.
Intracranial electroencephalogram (EEG) oscillatory rhythms from the valence circuits, including amygdala and, as available, the anterior insula, the dorsal anterior cingulate, and ventromedial prefrontal lobe will be measured during performance of the Affective Valence Perception Task.

Secondary Outcome Measures

Measure whether amygdala can be a suitable DBS target through comparison of EEG and reported perceptions.
Through administration of the electrical stimulation to the human amygdala while presenting participants with emotion producing pictures, researchers hope to analyze the differences in effects on reported perceptions by individual participants. These findings would allow to further determine whether the human amygdala is a suitable DBS target to treat certain psychiatric disorders.

Full Information

First Posted
March 14, 2022
Last Updated
October 13, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05292183
Brief Title
Modulation of Emotion Perception in Humans Via Amygdala Stimulation
Official Title
Neuromodulation of Affective Valence in Humans by Amygdala Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
Human Amygdala, Deep Brain Stimulation, Psychiatric Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
No stimulation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical Stimulation
Intervention Description
We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures.
Primary Outcome Measure Information:
Title
Better understand neural circuits responsible for processing valence as measured by the power in the gamma band in the valence circuit
Description
Intracranial electroencephalogram (EEG) oscillatory rhythms from the valence circuit, including the amygdala and, as available, the anterior insula, the dorsal anterior cingulate, and ventromedial prefrontal lobe will be measured during performance of the Affective Valence Perception Task.
Time Frame
Evaluated for each patient during monitoring period of approximately 2 weeks.
Title
Better understand the neural circuits responsible for processing valence by measuring negative and positive valence.
Description
Intracranial electroencephalogram (EEG) oscillatory rhythms from the valence circuits, including amygdala and, as available, the anterior insula, the dorsal anterior cingulate, and ventromedial prefrontal lobe will be measured during performance of the Affective Valence Perception Task.
Time Frame
Evaluated for each patient during monitoring period of approximately 2 weeks.
Secondary Outcome Measure Information:
Title
Measure whether amygdala can be a suitable DBS target through comparison of EEG and reported perceptions.
Description
Through administration of the electrical stimulation to the human amygdala while presenting participants with emotion producing pictures, researchers hope to analyze the differences in effects on reported perceptions by individual participants. These findings would allow to further determine whether the human amygdala is a suitable DBS target to treat certain psychiatric disorders.
Time Frame
Evaluated for each patient during monitoring period of approximately 2 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof A Bujarski, MD
Phone
603-650-5104
Email
krzysztof.a.bujarski@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasia Kanishcheva, MPH
Phone
603-650-0260
Email
Anastasia.Kanishcheva@Hitchcock.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof A Bujarski, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03776
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof A Bujarski, MD
Phone
603-650-5104
Email
krzysztof.a.bujarski@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Anastasia Kanishcheva, MPH
Phone
603-650-0260
Email
Anastasia.Kanishcheva@Hitchcock.ORG
First Name & Middle Initial & Last Name & Degree
Krzysztof A Bujarski, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.

Learn more about this trial

Modulation of Emotion Perception in Humans Via Amygdala Stimulation

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