Recruiting

Electrophysiology

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT05529264

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Memory Tasks

Attention/arousal tasks

Language tasks

Visuospatial tasks

Auditory Tasks

Study Details

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

Study ID

NCT05529264

Start date

Jan 17, 2023

Status verified date

Jan, 2026

Completion date

Aug 1, 2032

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.
  • 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

Enrollment

175 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Krzysztof A Bujarski, MD

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

Gina Kersey

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

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03776

Contacts

Krzysztof A Bujarski, MD

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

Gina Kersey

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

Principal Investigator:

Krzysztof A Bujarski, MD

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-01-15.