Effects of Social Feedback on Intracranial EEG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTrustees of Dartmouth College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Low social feedback
BehavioralSocial information is provided to participants signaling that the upcoming trial will be low in negative affect and cognitive effort.
High social feedback
BehavioralSocial information is provided to participants signaling that the upcoming trial will be high in negative affect and cognitive effort.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Random Order 1: Effects of social feedback on intracranial EEGExperimental treatment 2 interventions
Group B: Random Order 2: Effects of social feedback on intracranial EEGExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Ratings are made 3 to 10 seconds after experiencing each stimulus presented during task performance.2
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.
Time frame
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.
Time frame
Continuous recording during task performance, duration 1 hourSponsors and contacts
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Source ClinicalTrials.gov