Social InfluenceNCT06975800
Effects of Social Feedback on Intracranial EEG
A study testing Low social feedback and High social feedback in people with Social Influence and Epilepsy, run by Trustees of Dartmouth College at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Influence, Epilepsy
- What is being tested?
- Low social feedback and High social feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2023to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Krzysztof A Bujarski, Doctor of Medicine, krzysztof.a.bujarski@hitchcock.org
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. 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.
Read the detailed description
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.
- Conditions
- Social Influence, Epilepsy
- Being tested
- Low social feedback, High social feedback
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low social feedbackBehavioural
Social information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort.
High social feedbackBehavioural
Social information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Low social feedback; Behavioral: High social feedback |
| 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. Receives: Behavioral: Low social feedback; Behavioral: High social feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative affect ratings
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.
Measured: Ratings are made 3 to 10 seconds after experiencing each stimulus presented during task performance.
Cognitive effort ratings
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.
Measured: Ratings are made 3 to 10 seconds after experiencing each stimulus presented during task performance.
Secondary outcomes (1)
Intracranial neural responses to math problems and aversive fear-related images in the amygdala
Neural responses will be collected from participants using an iEEG electrode that is implanted by the care team for participant treatment for refractory epilepsy.
Measured: Continuous recording during task performance, duration 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start6 Apr 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InfluenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will watch videos of several doctors. Doctor videos will be presented that increase or decrease expected negative affect (the intervention) in a within-person crossover design. 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Wager, Trustees of Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975800
- Sponsor's protocol ID
- 467253
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators are strongly committed to contributing to open and reproducible science. All iEEG and behavioral data will be submitted to the NIMH Data Archive (NDA) according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute\_data\_sharing\_regimen.html ). The investigators will ensure that our IRB has approved our Data Sharing Plan. Scientists can use my information, without personal identifiers, for any kind of genetic research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Social Feedback on Intracranial EEG
- ClinicalTrials.gov ID
- NCT06975800
- Acronym / sponsor ID
- 467253
- Conditions
- Social Influence, Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will watch videos of several doctors. Doctor videos will be presented that increase or decrease expected negative affect (the intervention) in a within-person crossover design. 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).
| Arm | Type | Receives |
|---|---|---|
| Random Order 1: Effects of social feedback on intracranial EEG | Experimental | Behavioral: Low social feedback, Behavioral: High social feedbackParticipants 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. |
| Random Order 2: Effects of social feedback on intracranial EEG | Experimental | Behavioral: Low social feedback, Behavioral: High social feedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low social feedbackSocial information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort. | Behavioural | Random Order 1: Effects of social feedback on intracranial EEG, Random Order 2: Effects of social feedback on intracranial EEG |
| High social feedbackSocial information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort. | Behavioural | Random Order 1: Effects of social feedback on intracranial EEG, Random Order 2: Effects of social feedback on intracranial EEG |
Primary outcome
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.
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.
1 secondary outcome
Intracranial neural responses to math problems and aversive fear-related images in the amygdala
Time frame: Continuous recording during task performance, duration 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators are strongly committed to contributing to open and reproducible science. All iEEG and behavioral data will be submitted to the NIMH Data Archive (NDA) according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute_data_sharing_regimen.html ). The investigators will ensure that our IRB has approved our Data Sharing Plan. Scientists can use my information, without personal identifiers, for any kind of genetic research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low social feedback and High social feedback in people with Social Influence and Epilepsy, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tor D Wager, PhD (603-646-2196, Tor.D.Wager@Dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative affect ratings (time frame: Ratings are made 3 to 10 seconds after experiencing each stimulus presented during task performance.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.