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
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RECRUITING
NA
175 participants
INTERVENTIONAL
2023-01-17
2032-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Invasive EEG (electrodes are implanted in a participant's brain)
Patients with intracranial electrodes (electrodes are implanted in a participant's brain) undergoing pre-surgical evaluation for clinical reasons will be asked to participate in various study tasks with the recording of intracranial EEG (recording of brain waves via electrodes implanted in a participant's brain) during these tasks.
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.
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.
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.
Visuospatial tasks
Participants will be asked to copy 3 dimensional designs or make judgements of angle size.
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).
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.
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.
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.
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.
Scalp EEG (electrodes are placed on a participant's scalp)
Patients with non-invasive scalp electrodes who are admitted to the hospital for clinical reasons will be asked to participate in various study tasks with the recording of their EEG (recording of brain waves via electrodes attached to a participant's scalp) during these tasks.
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.
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.
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.
Visuospatial tasks
Participants will be asked to copy 3 dimensional designs or make judgements of angle size.
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).
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.
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.
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.
Normal Controls
Normal controls will be recruited from family members of patients, from advertisements, or from online tools. There will be no EEG recordings obtained from these participants.
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.
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.
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.
Visuospatial tasks
Participants will be asked to copy 3 dimensional designs or make judgements of angle size.
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.
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.
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.
Online Controls
Certain control subjects will be recruited through Amazon Mechanical Turk. These participants will be given their task on the online platform using Qualtric survey function. The task design will be identical to normal controls who are recruited in-person, with the exception of identifiers. There will be no EEG recordings obtained from these participants.
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.
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.
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.
Visuospatial tasks
Participants will be asked to copy 3 dimensional designs or make judgements of angle size.
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.
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.
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.
Interventions
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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.
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.
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.
Visuospatial tasks
Participants will be asked to copy 3 dimensional designs or make judgements of angle size.
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).
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients must have a diagnosis of refractory epilepsy undergoing intracranial EEG recording for clinical purposes.
* Patients must be age 18 years or older. There is no upper age limit.
* Patients must have a probable diagnosis of epilepsy.
* Participants must be age 18 years or older. There is no upper age limit.
* Participants must be able to provide informed consent for themselves.
Exclusion Criteria
* Patients are not able to provide informed consent for any reason (e.g. encephalopathic, experiencing a seizure)
* 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)
• Determined not to be appropriate normal control for the study population
18 Years
ALL
Yes
Sponsors
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Dartmouth College
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Krzysztof Bujarski
Section Chief, Neurology
Principal Investigators
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Krzysztof A Bujarski, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY02001606
Identifier Type: -
Identifier Source: org_study_id
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