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临床试验/NCT06975800
NCT06975800招募中不适用

Effects of Social Feedback on Intracranial EEG

Trustees of Dartmouth College2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Cognitive effort ratings

研究概览

简要总结

This study aims to assess the impact of social influence on direct neural recordings in human patients undergoing surgical treatment of epilepsy. 24 patients recruited from the Epilepsy Center at Dartmouth Health Medical Center (DHMC) will undergo electrode implantation throughout the brain to localize epileptogenic zones. Patients will be asked to rate their provider's warmth, competence, and other, similar traits associated with care-competency. They will then complete the picture-induced fear and math portions of the multimodal negative affect task (MNAT) during which iEEG is recorded.

详细描述

This study aims to assess the impact of social influence on direct neural recordings in human patients undergoing surgical treatment of epilepsy. A total of 24 patients, ranging in age from 18 to 65 years, will be recruited from the Epilepsy Center at Dartmouth Health Medical Center (DHMC), which serves a catchment area of approximately 2.5 million people in Northern New England. Patients eligible for intracranial electroencephalography (iEEG) are determined by a clinical-based multidisciplinary board, with 10-20 iEEG studies performed annually in the Epilepsy Monitoring Unit.

Each patient will undergo electrode implantation throughout the brain to localize epileptogenic zones, with 12-20 electrode leads implanted, each containing 8-18 channels. This results in a total of 150 to 220 channels of continuous electrophysiological data per patient. The iEEG signals will be recorded using a Natus clinical system, and precise timing synchronization will be ensured between the iEEG recordings and the experimental paradigm presentation.

The protocol will involve a single one-hour session for each patient. Patients will participate in a doctor rating task, where they provide impressions of warmth, competence, and other qualities related to the doctors presented in the experiment. Additionally, patients will perform a simplified version of the Multimodal Negative Affect Task (MNAT) used in Experiment 2, with the omission of pain stimuli to increase patient acceptability and reduce time and fatigue burden. Trial blocks will consist of brief videos of the doctors explaining what to expect in the upcoming trials, followed by four task trials involving fear or math stimuli from the MNAT task. Each doctor will have four threat-suggestion videos and four safety-suggestion videos, resulting in a total of 144 trials (8 doctors X 2 low/high threat cues X 3 repetitions x 4 trials per block).

The analysis of the neural data will involve time-frequency decomposition of local field potentials (LFPs) to examine broadband gamma-frequency power (40-200 Hz) locked to cue and stimulus onset time. Effects of cues (high vs. low-expectancy), self-reported fear or effort within each cue condition, and their interaction on broadband gamma signals will be assessed for each electrode contact. A focus will be placed on affect-encoding electrodes showing relationships with fear and/or effort within conditions. Proportions of affect-encoding electrodes and other contacts demonstrating social influence effects will be quantified. The analysis will also explore assimilation and contrast effects with cue-predicted values, investigating whether social information influences the neural correlates of affective experience.

To ensure appropriate sample size, it is anticipated that 10-15 eligible patients will participate each year during the project period. Biological sex differences and age will be controlled for in all analyses, and hypotheses will be tested while considering these factors. The study aims to provide valuable insights into the effects of social influence on neural activity, expanding our understanding of the mechanisms underlying placebo effects and affective experiences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must be between 18-65 years of age.
  • Patients must have a diagnosis of refractory epilepsy undergoing intracranial EEG recording for clinical purposes.
  • Patients with a legal guardian will be considered for participation if they are interested and, in the judgment of the research team, they are capable of performing the cognitive tasks required of the study. In those instances, the patient and their legal guardian will both participate in the informed consent process, with the legal guardian signing the consent form.

排除标准

  • Patient has additional neurological condition (such as stroke or dementia) or a psychiatric condition (such as active psychosis or suicidal ideation) and are deemed inappropriate for the study.
  • Patients are not able to provide informed consent for any reason (e.g. encephalopathic, experiencing a seizure).

研究组 & 干预措施

Random Order 1: Effects of social feedback on intracranial EEG

Experimental

Participants experience trials involving presentation of negative affective stimuli and an effort-demanding cognitive task. Trials are preceded by high or low social cues in random order.

干预措施: Low social feedback (Behavioral)

Random Order 1: Effects of social feedback on intracranial EEG

Experimental

Participants experience trials involving presentation of negative affective stimuli and an effort-demanding cognitive task. Trials are preceded by high or low social cues in random order.

干预措施: High social feedback (Behavioral)

Random Order 2: Effects of social feedback on intracranial EEG

Experimental

Participants experience trials involving presentation of negative affective stimuli and an effort-demanding cognitive task. Trials are preceded by high or low social cues in random order.

干预措施: Low social feedback (Behavioral)

Random Order 2: Effects of social feedback on intracranial EEG

Experimental

Participants experience trials involving presentation of negative affective stimuli and an effort-demanding cognitive task. Trials are preceded by high or low social cues in random order.

干预措施: High social feedback (Behavioral)

结局指标

主要结局

Cognitive effort ratings

时间窗: Ratings are made 3 to 10 seconds after experiencing each stimulus presented during task performance.

Participants report cognitive effort experience after each trial on a well-validated Generalized Linear Magnitude scale (GLMS) with anchors of "No effort" and "Most effort imaginable" . Scale is 0 to 100 with higher values indicating more effort.

Negative affect ratings

时间窗: Ratings are made 3 to 10 seconds after experiencing each stimulus presented during task performance.

Participants report subjective negative affect after each trial on a well-validated Generalized Linear Magnitude scale (GLMS) with anchors of "No negative affect" and"Most intense negative affect imaginable". Scale is 0 to 100 with higher values indicating more negative affect.

次要结局

  • Intracranial neural responses to math problems and aversive fear-related images in the amygdala(Continuous recording during task performance, duration 1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tor Wager

Diana L. Taylor Distinguished Professor

Trustees of Dartmouth College

研究点 (2)

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Effects of Social Feedback on Intracranial EEG | 临床试验