NCT05529264

Human Intracranial Electrophysiology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have electrodes implanted in the brain and/or have electrodes on the scalp. Additionally, this study will recruit normal and online controls (participants who do not have epilepsy). Participants will be asked to participate in 1 to 2 (30-90 minutes) daily sessions designed to test aspects of human cognition such as memory, speech, language, feeling, movement, attention, sound perception, and emotions. Generally, this will involve working on a computer, looking at pictures or watching videos, and answering questions. Additionally, participants may be asked to be hooked up to additional equipment such as eye tracker, electrical stimulator, heart rate monitor, sweat monitor or other non-invasive equipment. The overall aim of this study is to use human intracranial electrophysiology (the recording of the electrical activity of the human brain) to study localization and function of the human brain.

Detailed description

This project aims to study the mechanisms of brain function by using Human Intracranial Electrophysiology (HIE) methods and is a continuation of the "Localization of Human Brain Function" study done at Dartmouth-Hitchcock Medical Center (DHMC). HIE refers to the recording of brain signals using electrodes which are surgically inserted into the human brain for the clinical purpose of localizing the origins of epileptic seizures. Secondary to clinical goals, such patients with intracranial EEG electrodes can be safely recruited to participate in research studies, i.e. the research "piggybacks" on procedures that are performed strictly for a clinical purpose. Brain signals obtained using HIE methods during performance of specific tasks have unique properties rich with insight into the inner workings of the human brain. HIE methods can be used together with electrical brain stimulation (EBS) techniques to better understand relationship between brain and behavior. Furthermore, HIE methods can be recorded together with other non-invasive bio-physiological data streams such as pupillometry, electrodermal activity (EDA), cardiac monitoring, and respiratory monitoring to understand the relationship between the brain and many aspects of human physiology.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Memory Tasks	Participants will be asked to view pictures and videos presented on a computer screen and will be asked to recall the details of presented pictures or videos sometime later.
OTHER	Attention/arousal tasks	Participants will be asked to perform a continuous performance task, such as continuous addition of numbers. Additionally, participants may be presented with images and may be asked to rate the significance or arousal values for each image.
OTHER	Language tasks	Participants will be asked to view pictures of actions or things and will be asked to name them. Participants may also be asked to read words or passages.
OTHER	Visuospatial tasks	Participants will be asked to copy 3 dimensional designs or make judgements of angle size.
OTHER	Auditory Tasks	Participants will be presented with short, approximately 8-minute clips of music from various genres ( i.e. classical, country, rock, etc.) with an attention task (modified sustained attention to response task) nested within each trial. Participants will receive approximately 8 music stimuli and 1 control stimulus (pink noise) twice over the course of two testing sessions ( 90 mins each). Additionally, participants will be asked to answer questions about their hearing, music preferences/training, and certain demographic information (age, handedness, and language proficiency).
PROCEDURE	Brain Stimulation	A brain stimulator will be used to understand new functions of the brain. Participants will be presented with pictures on a computer screen and may be asked to tell researchers what is seen or remembered by participants. As pictures are viewed by the participants, the brain stimulator may be activated, which would not be something that would be felt by an individual participant.
OTHER	Social Emotional Task	Participants will be asked to view presented pictures and videos of people engaged in social interaction. Additionally, participants will be presented with the standardized tasks that are designed to help the researchers with understanding the nature of emotions. Some of these images may be emotionally disturbing. If participants are not comfortable viewing such images, they will be asked to refrain from participation in this study.
OTHER	Recording of facial expressions	Some participants may be asked permission to record the video of their facial expressions during performance of a research task. Generally, this will include only research tasks investigating brain representation of social/emotional information. Automated analysis of facial expression may be used in certain experiments to provide information on experience of emotional states such as happiness and sadness related to the images being presented.
OTHER	Judgement/Impulsivity Task	Certain study participants may be enrolled into research tasks designed to activate regions important for judgment and impulse control. These tasks will present participants with choices of varying monetary rewards and ask them to make judgements to measure one's tendency to prefer immediate over delayed rewards.

Timeline

• Start date: 2023-01-17
• Primary completion: 2027-08-01
• Completion: 2032-08-01
• First posted: 2022-09-07
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States