Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
24 participants
INTERVENTIONAL
2023-04-06
2028-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Virtual Contexts for Affective Modulation
NCT06986122
Feedbacks' Influence on Decision Making Processes
NCT02816632
Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study
NCT04634292
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette's Syndrome
NCT00664300
Cognitive Embodiment Activation by tDCS
NCT03094520
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
Patients will then perform a doctor rating task (reporting on their impressions of warmth, competence, and similar traits associated with care competency).
Trial blocks consist of a brief video of one of the 8 doctors previously rated by the participant. The doctor will explain what to expect on the upcoming Multimodal Negative Affect Task (MNAT) trials, followed by 4 task trials (fear or math, see Protection of Human Subjects for additional MNAT information). Video cues will include 4 threat-suggestion and 4 safety-suggestion videos for each doctor (8 doctors X 2 low/high threat cues X 3 repetitions x 4 trials per block, 144 total trials).
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Random Order 1: Effects of social feedback on intracranial EEG
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.
Low social feedback
Social information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort.
High social feedback
Social information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort.
Random Order 2: Effects of social feedback on intracranial EEG
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.
Low social feedback
Social information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort.
High social feedback
Social information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low social feedback
Social information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort.
High social feedback
Social information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients are not able to provide informed consent for any reason (e.g. encephalopathic, experiencing a seizure).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Trustees of Dartmouth College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tor Wager
Diana L. Taylor Distinguished Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
467253
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.