NCT05529264 · Dartmouth-Hitchcock Medical Center
Human Intracranial Electrophysiology
What this study is about
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).
View original scientific description
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.
Interventions
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.
Primary outcome measures
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 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 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 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 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 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Lebanon, New Hampshire
Collaborators
Dartmouth College
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations