Human Intracranial Electrophysiology
Purpose
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.
Condition
Eligibility
- Eligible Ages
-
Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
-
Yes
Inclusion Criteria
- Patients must be age 18 years or older. There is no upper age limit.
- Patients must have a diagnosis of refractory epilepsy undergoing intracranial EEG
recording for clinical purposes.
Patients with Intracranial EEG:
Exclusion Criteria
- 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)
Patients with Scalp EEG: Inclusion Criteria
- Patients must be age 18 years or older. There is no upper age limit.
- Patients must have a probable diagnosis of epilepsy.
Patients with Scalp EEG: Exclusion Criteria
- 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)
Normal Controls: Inclusion Criteria
- Participants must be age 18 years or older. There is no upper age limit.
- Participants must be able to provide informed consent for themselves.
Normal Controls: Exclusion Criteria
• Determined not to be appropriate normal control for the study population
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
Experimental 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.
|
-
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.
|
Experimental 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.
|
-
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).
-
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.
|
Active Comparator 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.
|
-
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: 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.
|
Active Comparator 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.
|
-
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: 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.
|
Recruiting Locations
Dartmouth-Hitchcock Medical Center
Lebanon,
New Hampshire
03776
More Details
- NCT ID
- NCT05529264
- Status
- Recruiting
- Sponsor
- Dartmouth-Hitchcock Medical Center
Study Contact
Krzysztof A Bujarski, MD
603-650-5104
krzysztof.a.bujarski@hitchcock.org
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.
Notice
Study information shown on this site is derived from
ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.