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Clinical Trials/NCT05529264
NCT05529264
Recruiting
Not Applicable

Human Intracranial Electrophysiology

Dartmouth-Hitchcock Medical Center1 site in 1 country175 target enrollmentJanuary 17, 2023

Overview

Phase
Not Applicable
Intervention
Memory Tasks
Conditions
Epilepsy
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
175
Locations
1
Primary Endpoint
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with memory.
Status
Recruiting
Last Updated
3 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 17, 2023
End Date
August 1, 2032
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Krzysztof Bujarski

Section Chief, Neurology

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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:

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.

Arms & Interventions

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.

Intervention: Memory Tasks

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.

Intervention: Attention/arousal tasks

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.

Intervention: Language tasks

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.

Intervention: Visuospatial tasks

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.

Intervention: Auditory Tasks

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.

Intervention: Brain Stimulation

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.

Intervention: Social Emotional Task

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.

Intervention: Recording of facial expressions

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.

Intervention: Judgement/Impulsivity Task

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.

Intervention: Memory Tasks

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.

Intervention: Attention/arousal tasks

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.

Intervention: Language tasks

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.

Intervention: Visuospatial tasks

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.

Intervention: Auditory Tasks

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.

Intervention: Memory Tasks

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.

Intervention: Social Emotional Task

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.

Intervention: Recording of facial expressions

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.

Intervention: Judgement/Impulsivity Task

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.

Intervention: Memory Tasks

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.

Intervention: Attention/arousal tasks

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.

Intervention: Language tasks

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.

Intervention: Visuospatial tasks

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.

Intervention: Social Emotional Task

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.

Intervention: Recording of facial expressions

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.

Intervention: Judgement/Impulsivity Task

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.

Intervention: Attention/arousal tasks

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.

Intervention: Language tasks

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.

Intervention: Visuospatial tasks

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.

Intervention: Social Emotional Task

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.

Intervention: Recording of facial expressions

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.

Intervention: Judgement/Impulsivity Task

Outcomes

Primary Outcomes

Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with memory.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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