Human Intracranial Electrophysiology

NCT05529264 | Recruiting

• 1 other identifier: STUDY02001606
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (6)

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

  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.

  Evaluated for each patient during monitoring period of approximately 2 weeks.

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

  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.

  Evaluated for each patient during monitoring period of approximately 2 weeks.

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

  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.

  Evaluated for each patient during monitoring period of approximately 2 weeks.

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

  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.

  Evaluated for each patient during monitoring period of approximately 2 weeks.

• Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with attention and executive function.

  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.

  Evaluated for each patient during monitoring period of approximately 2 weeks.

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

  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.

  Evaluated for each patient during monitoring period of approximately 2 weeks.

Secondary Outcomes (4)

• The degree of correlation between the brain activation and respiratory activity.

  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.

• 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.

Study Arms (4)

Invasive EEG (electrodes are implanted in a participant's brain)

EXPERIMENTAL

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; Other: Attention/arousal tasks; Other: Language tasks; Other: Visuospatial tasks; Other: Auditory Tasks; Procedure: Brain Stimulation; Other: Social Emotional Task; Other: Recording of facial expressions; Other: Judgement/Impulsivity Task

Scalp EEG (electrodes are placed on a participant's scalp)

EXPERIMENTAL

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; Other: Attention/arousal tasks; Other: Language tasks; Other: Visuospatial tasks; Other: Auditory Tasks; Other: Social Emotional Task; Other: Recording of facial expressions; Other: Judgement/Impulsivity Task

Normal Controls

ACTIVE COMPARATOR

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; Other: Attention/arousal tasks; Other: Language tasks; Other: Visuospatial tasks; Other: Social Emotional Task; Other: Recording of facial expressions; Other: Judgement/Impulsivity Task

Online Controls

ACTIVE COMPARATOR

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; Other: Attention/arousal tasks; Other: Language tasks; Other: Visuospatial tasks; Other: Social Emotional Task; Other: Recording of facial expressions; Other: Judgement/Impulsivity Task

Interventions

Language tasks OTHER

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.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Visuospatial tasks OTHER

Participants will be asked to copy 3 dimensional designs or make judgements of angle size.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Auditory Tasks OTHER

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).

Invasive EEG (electrodes are implanted in a participant's brain); Scalp EEG (electrodes are placed on a participant's scalp)

Memory Tasks OTHER

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.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Attention/arousal tasks OTHER

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.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Brain Stimulation PROCEDURE

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.

Invasive EEG (electrodes are implanted in a participant's brain)

Social Emotional Task OTHER

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.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Recording of facial expressions OTHER

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.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Judgement/Impulsivity Task OTHER

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.

Invasive EEG (electrodes are implanted in a participant's brain); Normal Controls; Online Controls; Scalp EEG (electrodes are placed on a participant's scalp)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 must be age 18 years or older. There is no upper age limit.
• Patients must have a probable diagnosis of epilepsy.
• 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)
• Participants must be age 18 years or older. There is no upper age limit.
• Participants must be able to provide informed consent for themselves.
• Determined not to be appropriate normal control for the study population

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03776, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Krzysztof A Bujarski, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof A Bujarski, MD

CONTACT

603-650-5104; krzysztof.a.bujarski@hitchcock.org

Gina Kersey

CONTACT

(603) 650-0260; Gina.E.Kersey@Hitchcock.ORG

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Neurology

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 7, 2022
• Study Start: January 17, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2032
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)