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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH124674-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation | Other | We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krzysztof A Bujarski, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03776 | United States |
The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.
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Of 15 patients who completed the study, EEG data was of adequate quality for analysis for four (4) patients, behavioral data with amygdala stimulation was available for nine (9) patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | This is the group that was recruited and were able to complete testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This population is the same as the recruited patients in participant flow
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| ID | Title | Description |
|---|---|---|
| BG000 | The Entire Study Population | 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 and no stimulation. All participants received sham and actual stimulation, however, the order in which the stimuli (with or without stimulation) were presented to the participants was computer randomized. The order in which the stimuli were presented was unique to each individual participant Electrical Stimulation: We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures. No Electrical stimulation: we will use a computer randomized sham stimulation of specific areas in the amygdala while showing a computer randomized set of pictures |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Electrophysiological data is available in 4 participants. | Posted | Mean | Standard Deviation | z-score | 0 to 1000 MS following image presentation |
during testing sessions for this study or 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Electrical Stimulation: We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Krzysztof Bujarski | Dartmouth-Hitchcock Medical Center | 603 650 5104 | krzysztof.a.bujarski@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2023 | Feb 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2023 | Feb 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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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.
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Gamma Power in the Amygdala According to Valence Category | This measure reflects changes in the activation of the amygdala when viewing images of specific emotional valence across all subjects. In our study, activation on intracranial EEG is measured by change in the power of the gamma band. This band is defined as frequency ranges from 30-100 Hz in intracranial EEG. An increase in gamma power reflects increased local neuronal activity during the cognitive process in question. Here we present neutral, positive, and negative valence images and determine change in gamma power for each valence category. Significant changes in gamma power from baseline is measured as z-score compared to baseline. |
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| Primary | 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. | These patients represent recruited patients that underwent stimulation of the amygdala during viewing of images of different valence. | Posted | Mean | Standard Deviation | units on a scale | Valence ratings were assessed immediately following the viewing of each image during performance of the task. |
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| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 1 | 15 |
| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Positive valence; stimulation |
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| Negative valence, no stimulation |
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| Negative valence, stimulation |
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