Neuromodulation of Affective Valence in Humans by Amygdala Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Z-score Gamma Power in Amygdala Per Valence Category
研究概览
简要总结
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.
详细描述
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. 2. Using brain stimulation to map function of certain parts of your brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Z-score Gamma Power in Amygdala Per Valence Category
时间窗: 0 to 1000 MS following image presentation
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).
Effect of Amygdala Stimulation on Perception of Valence
时间窗: Valence ratings were assessed immediately following the viewing of each image during performance of the task.
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.
次要结局
未报告次要终点
研究者
Krzysztof Bujarski
Section Chief, Neurology
Dartmouth-Hitchcock Medical Center