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High-density EEG in Neurological Disorders

Primary Purpose

Epilepsy, Tumor, Healthy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-density electroencephalogram (HD-EEG)
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring Electroencephalogram (EEG), Epilepsy, Lesion, Brain, Language, Movement, Sensation, Mapping, Dense-array EEG, High-density EEG, HD-EEG, stroke, Electrical Impedance Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

High-density EEG localization in epilepsy

High-density EEG localization in healthy controls

High-density EEG localization in tumor patients

High-density EEG localization in peripheral nerve patients

High-density EEG localization in stroke patients

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Localize brain functions in patients and healthy controls
Localize brain functions using high-density EEG recordings

Secondary Outcome Measures

Localize brain areas involved in language
Localize brain areas involved in language using high-density EEG recordings
Localize brain areas involved in movement
Localize brain areas involved in movement using high-density EEG recordings
Localize brain areas involved in sensation
Localize brain areas involved in sensation using high-density EEG recordings
Localize brain areas involved in emotion
Localize brain areas involved in emotion using high-density EEG recordings
Localize brain areas involved in memory
Localize brain areas involved in memory using high-density EEG recordings
Localize brain areas associated with lesions
Localize brain areas associated with lesions using high-density EEG recordings

Full Information

First Posted
February 10, 2020
Last Updated
July 31, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04266041
Brief Title
High-density EEG in Neurological Disorders
Official Title
High-density EEG in Neurological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
February 9, 2028 (Anticipated)
Study Completion Date
March 9, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.*

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Tumor, Healthy
Keywords
Electroencephalogram (EEG), Epilepsy, Lesion, Brain, Language, Movement, Sensation, Mapping, Dense-array EEG, High-density EEG, HD-EEG, stroke, Electrical Impedance Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-density EEG localization in epilepsy
Arm Type
Experimental
Arm Description
High-density EEG will be used for brain localization in epilepsy patients
Arm Title
High-density EEG localization in healthy controls
Arm Type
Active Comparator
Arm Description
High-density EEG will be used for brain localization in healthy controls
Arm Title
High-density EEG localization in tumor patients
Arm Type
Experimental
Arm Description
High-density EEG will be used for brain localization in tumor patients
Arm Title
High-density EEG localization in peripheral nerve patients
Arm Type
Experimental
Arm Description
High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction
Arm Title
High-density EEG localization in stroke patients
Arm Type
Experimental
Arm Description
High-density EEG will be used for brain localization in patients who have recently experienced a stroke
Intervention Type
Diagnostic Test
Intervention Name(s)
High-density electroencephalogram (HD-EEG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Localize brain functions in patients and healthy controls
Description
Localize brain functions using high-density EEG recordings
Time Frame
60 - 90 minutes
Secondary Outcome Measure Information:
Title
Localize brain areas involved in language
Description
Localize brain areas involved in language using high-density EEG recordings
Time Frame
60 - 90 minutes
Title
Localize brain areas involved in movement
Description
Localize brain areas involved in movement using high-density EEG recordings
Time Frame
60 - 90 minutes
Title
Localize brain areas involved in sensation
Description
Localize brain areas involved in sensation using high-density EEG recordings
Time Frame
60 - 90 minutes
Title
Localize brain areas involved in emotion
Description
Localize brain areas involved in emotion using high-density EEG recordings
Time Frame
60 - 90 minutes
Title
Localize brain areas involved in memory
Description
Localize brain areas involved in memory using high-density EEG recordings
Time Frame
60 - 90 minutes
Title
Localize brain areas associated with lesions
Description
Localize brain areas associated with lesions using high-density EEG recordings
Time Frame
60 - 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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High-density EEG in Neurological Disorders

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