Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.*
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-density EEG localization in epilepsy | Experimental | High-density EEG will be used for brain localization in epilepsy patients |
|
| High-density EEG localization in healthy controls | Active Comparator | High-density EEG will be used for brain localization in healthy controls |
|
| High-density EEG localization in tumor patients | Experimental | High-density EEG will be used for brain localization in tumor patients |
|
| High-density EEG localization in peripheral nerve patients | Experimental | High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Localize Brain Functions in Patients and Healthy Controls | Localize brain functions using high-density EEG recordings | At baseline for approximately 60 - 90 minutes |
| Localize Brain Areas Involved in Language |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High-density EEG Localization in Epilepsy | High-density EEG will be used for brain localization in epilepsy patients 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. |
| FG001 | High-density EEG Localization in Healthy Controls | High-density EEG will be used for brain localization in healthy controls 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. |
| FG002 | High-density EEG Localization in Tumor Patients | High-density EEG will be used for brain localization in tumor patients 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. |
| FG003 | High-density EEG Localization in Peripheral Nerve Patients | High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction 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. |
| FG004 | High-density EEG Localization in Stroke Patients | High-density EEG will be used for brain localization in patients who have recently experienced a stroke 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High-density EEG Localization in Epilepsy | High-density EEG will be used for brain localization in epilepsy patients 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We did not collect age information for the healthy control subjects for the purposes of protecting subjects' personal information. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 95 adult patients were enrolled in this study. Five subjects have already got neurostimulator (RNS or DBS) implanted before the study, of whom the HD-EEG data were excluded for further analysis. Two other subjects' recordings were excluded due to excessive electrical noise or faulty bulk connector. Therefore, 87 subjects with decent resting-state HD-EEG recordings were processed for spike detection. Interictal spikes were detected in the HD-EEG recordings of nearly 60% of subjects (n = 52). | Posted | Count of Participants | Participants | From 30-60 min HD-EEG recording, pre-operatively |
|
Adverse event data were collected from the consent through the end of participation for each subject (typically one day).
Adverse event collection for each participant was done from the time of consent through the end of study participation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-density EEG Localization in Epilepsy | High-density EEG will be used for brain localization in epilepsy patients 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Non-systematic Assessment | Stroke arm subject was consented and completed one HD-EEG study session. Six days later, the subject was admitted to Palliative Care and died two weeks later of ischemic stroke. The event was assessed to be not related to the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling of left scalp | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Stroke subject was consented to the study. During study testing, the subject reported tingling on the left side of their scalp, so the testing was stopped. The tingling was assessed to be probably related to the study. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yinchen Song | Dartmouth-Hitchcock Medical Center | 603-650-5104 | yinchen.song@hitchcock.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2024 | May 29, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: HD-EEG Informed Consent - Epilepsy | Jan 5, 2024 | May 29, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: HD-EEG Informed Consent - Healthy Subject | Jan 20, 2022 | May 29, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: HD-EEG Informed Consent - Peripheral Nerve | Jan 5, 2024 | May 29, 2025 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: HD-EEG Informed Consent - Stroke | Apr 22, 2022 | May 29, 2025 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: HD-EEG Informed Consent - Tumor | Sep 26, 2019 | May 29, 2025 | ICF_005.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D009369 | Neoplasms |
| D007802 | Language |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003142 | Communication |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Localize brain areas involved in language using high-density EEG recordings
| At baseline for approximately 60 - 90 minutes |
| Localize Brain Areas Involved in Movement | Localize brain areas involved in movement using high-density EEG recordings | At baseline for approximately 60 - 90 minutes |
| Localize Brain Areas Involved in Sensation | Localize brain areas involved in sensation using high-density EEG recordings | At baseline for approximately 60 - 90 minutes |
| Localize Brain Areas Associated With Lesions | Localize brain areas associated with lesions using high-density EEG recordings | At baseline for approximately 60 - 90 minutes |
| BG001 | High-density EEG Localization in Healthy Controls | High-density EEG will be used for brain localization in healthy controls 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. |
| BG002 | High-density EEG Localization in Tumor Patients | High-density EEG will be used for brain localization in tumor patients 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. |
| BG003 | High-density EEG Localization in Peripheral Nerve Patients | High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction 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. |
| BG004 | High-density EEG Localization in Stroke Patients | High-density EEG will be used for brain localization in patients who have recently experienced a stroke 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. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 3 patients did the study twice with different subject IDs. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 3 patients did the study twice with different subject IDs. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 3 patients did the study twice with different subject IDs. | Count of Participants | Participants |
|
| Region of Enrollment | 3 patients did the study twice with different subject IDs. | Number | participants |
|
High-density EEG will be used for brain localization in epilepsy patients
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.
|
|
| Secondary | Localize Brain Functions in Patients and Healthy Controls | Localize brain functions using high-density EEG recordings | healthy control only had sensory and language tasks. Tumor patient only had motor and sensory tasks, also underwent resting-state recording to localize lesion. Peripheral nerve patients only had motor and sensory tasks. Stroke patients only had electrical impedance study to localize the lesion. | Posted | Count of Participants | Participants | At baseline for approximately 60 - 90 minutes |
|
|
|
| Secondary | Localize Brain Areas Involved in Language | Localize brain areas involved in language using high-density EEG recordings | all normal subjects | Posted | Count of Participants | Participants | At baseline for approximately 60 - 90 minutes |
|
|
|
| Secondary | Localize Brain Areas Involved in Movement | Localize brain areas involved in movement using high-density EEG recordings | Posted | Count of Participants | Participants | At baseline for approximately 60 - 90 minutes |
|
|
|
| Secondary | Localize Brain Areas Involved in Sensation | Localize brain areas involved in sensation using high-density EEG recordings | Posted | Count of Participants | Participants | At baseline for approximately 60 - 90 minutes |
|
|
|
| Secondary | Localize Brain Areas Associated With Lesions | Localize brain areas associated with lesions using high-density EEG recordings | Posted | Count of Participants | Participants | At baseline for approximately 60 - 90 minutes |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | High-density EEG Localization in Healthy Controls | High-density EEG will be used for brain localization in healthy controls 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | High-density EEG Localization in Tumor Patients | High-density EEG will be used for brain localization in tumor patients 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | High-density EEG Localization in Peripheral Nerve Patients | High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | High-density EEG Localization in Stroke Patients | High-density EEG will be used for brain localization in patients who have recently experienced a stroke 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. | 1 | 7 | 2 | 7 | 1 | 7 |
|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment | Stroke subject was consented and completed one HD-EEG Study session. Four days later, subject made an unsuccessful suicide attempt. Event assessed to be unlikely related to the study. |
|
|
Not provided
Not provided
Not provided
| D001519 |
| Behavior |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Alpha for motor |
|
|
| Somatosensory evoked potential |
|
|
| Lesion |
|
|
|