High-density EEG in Neurological Disorders

July 31, 2023 updated by: Yinchen Song, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.*

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-density EEG localization in epilepsy
High-density EEG will be used for brain localization in epilepsy patients
Diagnostic test: 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.
Active Comparator: High-density EEG localization in healthy controls
High-density EEG will be used for brain localization in healthy controls
Diagnostic test: 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.
Experimental: High-density EEG localization in tumor patients
High-density EEG will be used for brain localization in tumor patients
Diagnostic test: 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.
Experimental: High-density EEG localization in peripheral nerve patients
High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction
Diagnostic test: 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.
Experimental: High-density EEG localization in stroke patients
High-density EEG will be used for brain localization in patients who have recently experienced a stroke
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localize brain functions in patients and healthy controls
Time Frame: 60 - 90 minutes
Localize brain functions using high-density EEG recordings
60 - 90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localize brain areas involved in language
Time Frame: 60 - 90 minutes
Localize brain areas involved in language using high-density EEG recordings
60 - 90 minutes
Localize brain areas involved in movement
Time Frame: 60 - 90 minutes
Localize brain areas involved in movement using high-density EEG recordings
60 - 90 minutes
Localize brain areas involved in sensation
Time Frame: 60 - 90 minutes
Localize brain areas involved in sensation using high-density EEG recordings
60 - 90 minutes
Localize brain areas involved in emotion
Time Frame: 60 - 90 minutes
Localize brain areas involved in emotion using high-density EEG recordings
60 - 90 minutes
Localize brain areas involved in memory
Time Frame: 60 - 90 minutes
Localize brain areas involved in memory using high-density EEG recordings
60 - 90 minutes
Localize brain areas associated with lesions
Time Frame: 60 - 90 minutes
Localize brain areas associated with lesions using high-density EEG recordings
60 - 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2018

Primary Completion (Estimated)

February 9, 2028

Study Completion (Estimated)

March 9, 2028

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D18111 30813

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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