High-density EEG in Neurological Disorders

NCT04266041 | Completed Results FDA Device

• 1 other identifier: D18111 30813
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Localizing Brain Regions That Generate Interictal Spikes

  The frequency of detecting interictal spikes in HD-EEG The distance between the source location determined by electrical source imaging and the spike locations determined by SEEG studies

  From 30-60 min HD-EEG recording, pre-operatively

Secondary Outcomes (5)

• Localize Brain Functions in Patients and Healthy Controls

  At baseline for approximately 60 - 90 minutes

• Localize Brain Areas Involved in Language

  At baseline for approximately 60 - 90 minutes

• Localize Brain Areas Involved in Movement

  At baseline for approximately 60 - 90 minutes

• Localize Brain Areas Involved in Sensation

  At baseline for approximately 60 - 90 minutes

• Localize Brain Areas Associated With Lesions

  At baseline for approximately 60 - 90 minutes

Study Arms (5)

High-density EEG localization in epilepsy

EXPERIMENTAL

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

Diagnostic Test: High-density electroencephalogram (HD-EEG)

High-density EEG localization in healthy controls

ACTIVE COMPARATOR

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

Diagnostic Test: High-density electroencephalogram (HD-EEG)

High-density EEG localization in tumor patients

EXPERIMENTAL

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

Diagnostic Test: High-density electroencephalogram (HD-EEG)

High-density EEG localization in peripheral nerve patients

EXPERIMENTAL

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

Diagnostic Test: High-density electroencephalogram (HD-EEG)

High-density EEG localization in stroke patients

EXPERIMENTAL

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

Diagnostic Test: High-density electroencephalogram (HD-EEG)

Interventions

High-density electroencephalogram (HD-EEG) 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 epilepsy; High-density EEG localization in healthy controls; High-density EEG localization in peripheral nerve patients; High-density EEG localization in stroke patients; High-density EEG localization in tumor patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy; Neoplasms; Language; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication; Behavior; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Yinchen Song
• Organization: Dartmouth-Hitchcock Medical Center

yinchen.song@hitchcock.org

603-650-5104

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neurophysiologist, Neuro Diagnostics

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: February 9, 2018
• Primary Completion: May 31, 2024
• Study Completion: December 13, 2024
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-11

Locations

US (1)