NCT04266041

High-density EEG in Neurological Disorders

Completed NA Results posted Last updated 12 December 2025

What this trial tests

NA trial testing High-density electroencephalogram (HD-EEG) in Epilepsy in 122 participants. Completed in 13 December 2024.

Timeline

9 February 2018

Primary endpoint
31 May 2024

13 December 2024

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	122
Start date	9 February 2018
Primary completion	31 May 2024
Estimated completion	13 December 2024
Sites	1 location across United States

Drugs / interventions tested

• High-density electroencephalogram (HD-EEG)

Conditions studied

• Epilepsy — all drugs for Epilepsy →
• Tumor — all drugs for Tumor →
• Healthy — all drugs for Healthy →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Epilepsy or Tumor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Localizing Brain Regions That Generate Interictal Spikes Primary · From 30-60 min HD-EEG recording, pre-operatively

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

Group	Value	95% CI
High-density EEG Localization in Epilepsy	52

Localize Brain Functions in Patients and Healthy Controls Secondary · At baseline for approximately 60 - 90 minutes

Localize brain functions using high-density EEG recordings

High-gamma for language

Group	Value	95% CI
High-density EEG Localization in Healthy Controls	12

Alpha for motor

Group	Value	95% CI
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Peripheral Nerve Patients	0

Somatosensory evoked potential

Group	Value	95% CI
High-density EEG Localization in Healthy Controls	1
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Peripheral Nerve Patients	0

Lesion

Group	Value	95% CI
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Stroke Patients	4

Localize Brain Areas Involved in Language Secondary · At baseline for approximately 60 - 90 minutes

Localize brain areas involved in language using high-density EEG recordings

Feasible to complete the language task

Group	Value	95% CI
High-density EEG Localization in Healthy Controls	12

high-gamma activity localized to suspected language area

Group	Value	95% CI
High-density EEG Localization in Healthy Controls	12

Localize Brain Areas Involved in Movement Secondary · At baseline for approximately 60 - 90 minutes

Localize brain areas involved in movement using high-density EEG recordings

Tolerated motor task

Group	Value	95% CI
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Peripheral Nerve Patients	4

Alpha band activity localized to motor area

Group	Value	95% CI
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Peripheral Nerve Patients	0

Localize Brain Areas Involved in Sensation Secondary · At baseline for approximately 60 - 90 minutes

Localize brain areas involved in sensation using high-density EEG recordings

Tolerated Sensory task

Group	Value	95% CI
High-density EEG Localization in Healthy Controls	12
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Peripheral Nerve Patients	4

Somatosensory evoked potential captured

Group	Value	95% CI
High-density EEG Localization in Healthy Controls	1
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Peripheral Nerve Patients	0

Localize Brain Areas Associated With Lesions Secondary · At baseline for approximately 60 - 90 minutes

Localize brain areas associated with lesions using high-density EEG recordings

Tolerated resting-state recording

Group	Value	95% CI
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Stroke Patients	7

Abnormality localized

Group	Value	95% CI
High-density EEG Localization in Tumor Patients	1
High-density EEG Localization in Stroke Patients	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from the consent through the end of participation for each subject (typically one day).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High-density EEG Localization in Epilepsy

Serious: 0/95 (0%)

Deaths: 0/95

High-density EEG Localization in Healthy Controls

Serious: 0/12 (0%)

Deaths: 0/12

High-density EEG Localization in Tumor Patients

Serious: 0/1 (0%)

Deaths: 0/1

High-density EEG Localization in Peripheral Nerve Patients

Serious: 0/4 (0%)

Deaths: 0/4

High-density EEG Localization in Stroke Patients

Serious: 2/7 (29%)

Deaths: 1/7

Serious adverse events (2 terms)

Reaction	System	High-density EEG Localizat…	High-density EEG Localizat…	High-density EEG Localizat…	High-density EEG Localizat…	High-density EEG Localizat…
Death	Vascular disorders	—	—	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	High-density EEG Localizat…	High-density EEG Localizat…	High-density EEG Localizat…	High-density EEG Localizat…	High-density EEG Localizat…
Tingling of left scalp	Skin and subcutaneous tissue disorders	—	—	—	—	—

Most-reported serious reactions: Death, Suicide attempt.

Data from ClinicalTrials.gov NCT04266041 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.