Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06975800

Effects of Social Feedback on Intracranial EEG

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location status: Recruiting

Location contact

Krzysztof A Bujarski, Doctor of Medicine

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Low social feedback

Behavioral

Social information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort.

High social feedback

Behavioral

Social information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort.

Primary outcomes

  1. Negative affect ratings

    Time frame: 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.

  2. Cognitive effort ratings

    Time frame: 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.

Secondary outcomes

  1. Intracranial neural responses to math problems and aversive fear-related images in the amygdala

    Time frame: Continuous recording during task performance, duration 1 hour

    Neural responses will be collected from participants using an iEEG electrode that is implanted by the care team for participant treatment for refractory epilepsy.

Study contacts

Contact information is provided by the study sponsor or research team.

Tor D Wager, PhD

CONTACT

[email protected]

603-646-2196

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 16, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.