High-density EEG in Neurological Disorders

NCT ID: NCT04266041

Last Updated: 2025-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2024-12-13

Brief Summary

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The purpose of the study is to use a new method of high-density electroencephalogram (HD-EEG) recording to map brain areas important for movement, sensation, language, emotion, and cognition.

Detailed Description

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This study will measure brain waves using high-density EEG. Participants will be asked wear a cap with electrodes attached to it. During the recording, participants may be asked to rest, sleep, or complete a task. The tasks involve viewing pictures, answering questions, speaking, or moving an arm or leg. Recordings generally last between 60-120 minutes.\*

Conditions

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Epilepsy Tumor Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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High-density EEG localization in epilepsy

High-density EEG will be used for brain localization in epilepsy patients

Group Type EXPERIMENTAL

High-density electroencephalogram (HD-EEG)

Intervention Type DIAGNOSTIC_TEST

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density EEG localization in healthy controls

High-density EEG will be used for brain localization in healthy controls

Group Type ACTIVE_COMPARATOR

High-density electroencephalogram (HD-EEG)

Intervention Type DIAGNOSTIC_TEST

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density EEG localization in tumor patients

High-density EEG will be used for brain localization in tumor patients

Group Type EXPERIMENTAL

High-density electroencephalogram (HD-EEG)

Intervention Type DIAGNOSTIC_TEST

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density EEG localization in peripheral nerve patients

High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction

Group Type EXPERIMENTAL

High-density electroencephalogram (HD-EEG)

Intervention Type DIAGNOSTIC_TEST

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density EEG localization in stroke patients

High-density EEG will be used for brain localization in patients who have recently experienced a stroke

Group Type EXPERIMENTAL

High-density electroencephalogram (HD-EEG)

Intervention Type DIAGNOSTIC_TEST

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

Interventions

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High-density electroencephalogram (HD-EEG)

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Able to perform the tasks
* Able to give own consent

Exclusion Criteria

* Any neurologic or psychiatric diagnosis such as stroke, tumor, or psychosis judged to interfere with high-density EEG.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yinchen Song

Clinical Neurophysiologist, Neuro Diagnostics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: HD-EEG Informed Consent - Epilepsy

View Document

Document Type: Informed Consent Form: HD-EEG Informed Consent - Healthy Subject

View Document

Document Type: Informed Consent Form: HD-EEG Informed Consent - Peripheral Nerve

View Document

Document Type: Informed Consent Form: HD-EEG Informed Consent - Stroke

View Document

Document Type: Informed Consent Form: HD-EEG Informed Consent - Tumor

View Document

Other Identifiers

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D18111 30813

Identifier Type: -

Identifier Source: org_study_id

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