Human Intracranial Electrophysiology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with memory.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Intracranial EEG: 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:
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Memory Tasks (Other)
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.
干预措施: Attention/arousal tasks (Other)
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.
干预措施: Language tasks (Other)
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.
干预措施: Visuospatial tasks (Other)
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.
干预措施: Auditory Tasks (Other)
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.
干预措施: Brain Stimulation (Procedure)
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.
干预措施: Social Emotional Task (Other)
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.
干预措施: Recording of facial expressions (Other)
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.
干预措施: Judgement/Impulsivity Task (Other)
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.
干预措施: Memory Tasks (Other)
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.
干预措施: Attention/arousal tasks (Other)
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.
干预措施: Language tasks (Other)
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.
干预措施: Visuospatial tasks (Other)
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.
干预措施: Auditory Tasks (Other)
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.
干预措施: Memory Tasks (Other)
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.
干预措施: Social Emotional Task (Other)
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.
干预措施: Recording of facial expressions (Other)
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.
干预措施: Judgement/Impulsivity Task (Other)
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.
干预措施: Memory Tasks (Other)
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.
干预措施: Attention/arousal tasks (Other)
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.
干预措施: Language tasks (Other)
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.
干预措施: Visuospatial tasks (Other)
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.
干预措施: Social Emotional Task (Other)
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.
干预措施: Recording of facial expressions (Other)
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.
干预措施: Judgement/Impulsivity Task (Other)
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.
干预措施: Attention/arousal tasks (Other)
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.
干预措施: Language tasks (Other)
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.
干预措施: Visuospatial tasks (Other)
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.
干预措施: Social Emotional Task (Other)
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.
干预措施: Recording of facial expressions (Other)
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.
干预措施: Judgement/Impulsivity Task (Other)
结局指标
主要结局
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with memory.
时间窗: Evaluated for each patient during monitoring period of approximately 2 weeks.
Primary objective is to use human intracranial electrophysiology to study localization and function of the human brain. With continuous recording of the electrical activity in participants' brain, study participants will be asked to take part in research tasks involving memory. The researchers will use the information to further the understanding of the exact location of cognitive functions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with emotions.
时间窗: Evaluated for each patient during monitoring period of approximately 2 weeks.
Primary objective is to use human intracranial electrophysiology to study localization and function of the human brain. With continuous recording of the electrical activity in participants' brain, study participants will be asked to take part in research tasks involving emotions. The researchers will use the information to further the understanding of the exact location of cognitive functions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with attention and executive function.
时间窗: Evaluated for each patient during monitoring period of approximately 2 weeks.
Primary objective is to use human intracranial electrophysiology to study localization and function of the human brain. With continuous recording of the electrical activity in participants' brain, study participants will be asked to take part in research tasks involving attention and executive function. The researchers will use the information to further the understanding of the exact location of cognitive functions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with movement.
时间窗: Evaluated for each patient during monitoring period of approximately 2 weeks.
Primary objective is to use human intracranial electrophysiology to study localization and function of the human brain. With continuous recording of the electrical activity in participants' brain, study participants will be asked to take part in research tasks involving movement. The researchers will use the information to further the understanding of the exact location of cognitive functions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with language.
时间窗: Evaluated for each patient during monitoring period of approximately 2 weeks.
Primary objective is to use human intracranial electrophysiology to study localization and function of the human brain. With continuous recording of the electrical activity in participants' brain, study participants will be asked to take part in research tasks involving language. The researchers will use the information to further the understanding of the exact location of cognitive functions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with sound perception.
时间窗: Evaluated for each patient during monitoring period of approximately 2 weeks.
Primary objective is to use human intracranial electrophysiology to study localization and function of the human brain. With continuous recording of the electrical activity in participants' brain, study participants will be asked to take part in research tasks involving sound perception. The researchers will use the information to further the understanding of the exact location of cognitive functions.
次要结局
- The degree of correlation between the brain activation and respiratory activity.(Evaluated for each patient during monitoring period of approximately 2 weeks.)
- Measure the degree of correlation between the brain activation and sweat variations.(Evaluated for each patient during monitoring period of approximately 2 weeks.)
- Measure the degree of correlation between the brain activation and cardiac physiology.(Evaluated for each patient during monitoring period of approximately 2 weeks.)
- The degree of correlation between the brain activation and electrodermal activity.(Evaluated for each patient during monitoring period of approximately 2 weeks.)
研究者
Krzysztof Bujarski
Section Chief, Neurology
Dartmouth-Hitchcock Medical Center