Epilepsy, Healthy, Tumor
Conditions
Keywords
Electroencephalogram (EEG), Epilepsy, Lesion, Brain, Language, Movement, Sensation, Mapping, Dense-array EEG, High-density EEG, HD-EEG, stroke, Electrical Impedance Tomography
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.\*
Interventions
DIAGNOSTIC_TESTHigh-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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Localizing Brain Regions That Generate Interictal Spikes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Localize Brain Functions in Patients and Healthy Controls | At baseline for approximately 60 - 90 minutes | Localize brain functions using high-density EEG recordings |
| Localize Brain Areas Involved in Language | At baseline for approximately 60 - 90 minutes | Localize brain areas involved in language using high-density EEG recordings |
| Localize Brain Areas Involved in Movement | At baseline for approximately 60 - 90 minutes | Localize brain areas involved in movement using high-density EEG recordings |
| Localize Brain Areas Involved in Sensation | At baseline for approximately 60 - 90 minutes | Localize brain areas involved in sensation using high-density EEG recordings |
| Localize Brain Areas Associated With Lesions | At baseline for approximately 60 - 90 minutes | Localize brain areas associated with lesions using high-density EEG recordings |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 95 |
| 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. | 12 |
| 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. | 1 |
| 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. | 4 |
| 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. | 7 |
| Total | 119 |
Baseline characteristics
| Characteristic | High-density EEG Localization in Epilepsy | Total | High-density EEG Localization in Stroke Patients | High-density EEG Localization in Peripheral Nerve Patients | High-density EEG Localization in Tumor Patients | High-density EEG Localization in Healthy Controls |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.55 years STANDARD_DEVIATION 13.19 | 40.59 years STANDARD_DEVIATION 16.22 | 74.38 years STANDARD_DEVIATION 10.42 | 42.75 years STANDARD_DEVIATION 10.44 | 72 years STANDARD_DEVIATION 0 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 112 Participants | 7 Participants | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) White | 92 Participants | 108 Participants | 7 Participants | 4 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 95 participants | 119 participants | 6 participants | 4 participants | 1 participants | 12 participants |
| Sex: Female, Male Female | 38 Participants | 44 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 57 Participants | 75 Participants | 6 Participants | 2 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 12 | 0 / 1 | 0 / 4 | 1 / 7 |
| other Total, other adverse events | 0 / 95 | 0 / 12 | 0 / 1 | 0 / 4 | 1 / 7 |
| serious Total, serious adverse events | 0 / 95 | 0 / 12 | 0 / 1 | 0 / 4 | 2 / 7 |
Outcome results
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
Time frame: From 30-60 min HD-EEG recording, pre-operatively
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-density EEG Localization in Epilepsy | Localizing Brain Regions That Generate Interictal Spikes | 52 Participants |
Secondary
Localize Brain Areas Associated With Lesions
Localize brain areas associated with lesions using high-density EEG recordings
Time frame: At baseline for approximately 60 - 90 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-density EEG Localization in Epilepsy | Localize Brain Areas Associated With Lesions | Tolerated resting-state recording | 1 Participants |
| High-density EEG Localization in Epilepsy | Localize Brain Areas Associated With Lesions | Abnormality localized | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Areas Associated With Lesions | Tolerated resting-state recording | 7 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Areas Associated With Lesions | Abnormality localized | 4 Participants |
Secondary
Localize Brain Areas Involved in Language
Localize brain areas involved in language using high-density EEG recordings
Time frame: At baseline for approximately 60 - 90 minutes
Population: all normal subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-density EEG Localization in Epilepsy | Localize Brain Areas Involved in Language | Feasible to complete the language task | 12 Participants |
| High-density EEG Localization in Epilepsy | Localize Brain Areas Involved in Language | high-gamma activity localized to suspected language area | 12 Participants |
Secondary
Localize Brain Areas Involved in Movement
Localize brain areas involved in movement using high-density EEG recordings
Time frame: At baseline for approximately 60 - 90 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-density EEG Localization in Epilepsy | Localize Brain Areas Involved in Movement | Alpha band activity localized to motor area | 1 Participants |
| High-density EEG Localization in Epilepsy | Localize Brain Areas Involved in Movement | Tolerated motor task | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Areas Involved in Movement | Alpha band activity localized to motor area | 0 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Areas Involved in Movement | Tolerated motor task | 4 Participants |
Secondary
Localize Brain Areas Involved in Sensation
Localize brain areas involved in sensation using high-density EEG recordings
Time frame: At baseline for approximately 60 - 90 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-density EEG Localization in Epilepsy | Localize Brain Areas Involved in Sensation | Tolerated Sensory task | 12 Participants |
| High-density EEG Localization in Epilepsy | Localize Brain Areas Involved in Sensation | Somatosensory evoked potential captured | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Areas Involved in Sensation | Tolerated Sensory task | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Areas Involved in Sensation | Somatosensory evoked potential captured | 1 Participants |
| High-density EEG Localization in Peripheral Nerve Patients | Localize Brain Areas Involved in Sensation | Tolerated Sensory task | 4 Participants |
| High-density EEG Localization in Peripheral Nerve Patients | Localize Brain Areas Involved in Sensation | Somatosensory evoked potential captured | 0 Participants |
Secondary
Localize Brain Functions in Patients and Healthy Controls
Localize brain functions using high-density EEG recordings
Time frame: At baseline for approximately 60 - 90 minutes
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-density EEG Localization in Epilepsy | Localize Brain Functions in Patients and Healthy Controls | High-gamma for language | 12 Participants |
| High-density EEG Localization in Epilepsy | Localize Brain Functions in Patients and Healthy Controls | Somatosensory evoked potential | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Functions in Patients and Healthy Controls | Somatosensory evoked potential | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Functions in Patients and Healthy Controls | Alpha for motor | 1 Participants |
| High-density EEG Localization in Tumor Patients | Localize Brain Functions in Patients and Healthy Controls | Lesion | 1 Participants |
| High-density EEG Localization in Peripheral Nerve Patients | Localize Brain Functions in Patients and Healthy Controls | Somatosensory evoked potential | 0 Participants |
| High-density EEG Localization in Peripheral Nerve Patients | Localize Brain Functions in Patients and Healthy Controls | Alpha for motor | 0 Participants |
| High-density EEG Localization in Stroke Patients | Localize Brain Functions in Patients and Healthy Controls | Lesion | 4 Participants |