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Brain Function Study for Epilepsy

N/A

Recruiting

Led By Krzysztof A Bujarski, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated for each patient during monitoring period of approximately 2 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll epilepsy patients who have electrodes in their brain or on their scalp, as well as normal and online controls. The aim is to study localization and function of the human brain using intracranial electrophysiology.

Who is the study for?

This trial is for adults with refractory epilepsy who are undergoing clinical intracranial EEG recording as part of their evaluation for epilepsy surgery. It also includes healthy individuals and online participants without epilepsy to serve as controls.

What is being tested?

The study tests various aspects of human cognition in patients with electrodes implanted in the brain or on the scalp, using tasks related to memory, speech, emotions, etc., often involving computers and additional non-invasive monitoring equipment.

What are the potential side effects?

Since this study involves cognitive testing and non-invasive monitoring rather than drug treatments, side effects may include discomfort from wearing monitoring devices or fatigue from participating in lengthy cognitive tasks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated for each patient during monitoring period of approximately 2 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated for each patient during monitoring period of approximately 2 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated for each patient during monitoring period of approximately 2 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+3 more

Secondary study objectives

Measure the degree of correlation between the brain activation and cardiac physiology.

Measure the degree of correlation between the brain activation and sweat variations.

The degree of correlation between the brain activation and electrodermal activity.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Scalp EEG (electrodes are placed on a participant's scalp)Experimental Treatment8 Interventions

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.

Group II: Invasive EEG (electrodes are implanted in a participant's brain)Experimental Treatment9 Interventions

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.

Group III: Normal ControlsActive Control7 Interventions

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.

Group IV: Online ControlsActive Control7 Interventions

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.

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