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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS074450-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.
The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microelectrodes | Experimental | Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microelectrodes | Device | Microelectrode implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons. | With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated. | Evaluated for each patient during monitoring period of approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage). | Secondary objective is to investigate whether it is possible to predict the speed of which each participant is performing and navigating during the cognitive task via the intracranial spectral EEG changes (alpha, beta, delta, theta, gamma, and high-gamma) during these tasks. Accuracy of frequency band (brain waves) predicting speed during specific cognitive tasks is measured by how precisely the frequency band predicts navigational speed and is expressed as a percentage of correct prediction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara C Jobst, MD, PhD | Section Chief of Adult Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microelectrodes | Patients who qualify for this study were implanted with standard electrodes that in addition have microelectrodes embedded in the standard macroelectrodes that are standard of care in epilepsy surgery. Microelectrodes have been shown to record single unit potentials and more localized field potentials on EEG recordings. There is no control group as patient serve as their own control. The patient is presented with a cognitive task and signals are recorded during the cognitive task, the signals during the different elements of the cognitive task are compared to each other or compared to a baseline state. There is no therapeutic intervention tested, the study is aimed to understand cognitive memory processing and translate animal studies to humans that have described successful memory encoding with certain EEG signals (place cells, theta oscillations) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Microelectrodes | Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring. Microelectrodes: Microelectrode implantation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility of Microelectrode Technology to Isolate Place Responsive Neurons in the Human Hippocampus as Measured by the Number of Place Responsive Neurons. | With the occipito-temporal implantation approach of implantation of microelectrodes, feasibility will measured by the number of place responsive neurons that could be isolated. | Participants included patients undergoing intra-cranial EEG monitoring for TLE and are implanted with depth electrodes and microelectrodes via the trans-occipital approach. The total number of place responsive neurons recorded from all participants is reported below. | Posted | Number | place responsive neurons | Evaluated for each patient during monitoring period of approximately 2 weeks |
|
Evaluated for each patient during monitoring period of approximately 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microelectrodes | Patients who qualify for this study will be implanted with standard electrodes as well as microelectrodes for their intracranial seizure monitoring. Microelectrodes: Microelectrode implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment | Subject had post operative wound infection following craniotomy. This was recorded as a serious adverse event that was unrelated to the study procedure. |
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Too few single units were recorded, and it was not possible to identify the units as place cells.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Jobst | Dartmouth-Hitchcock Medical Center | 6036505000 | Barbara.C.Jobst@hitchcock.org |
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| 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 | Jun 22, 2020 | May 25, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2014 | Mar 14, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008839 | Microelectrodes |
| ID | Term |
|---|---|
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Evaluated for each patient during monitoring period of approximately 2 weeks |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
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| Secondary | How Precise the Frequencies (Alpha, Beta, Delta, Theta, Gamma, and High-gamma) of Neural Brain Activity Predict the Speed of the Participant at Performing the Cognitive Task (Accuracy Measured in Percentage). | Secondary objective is to investigate whether it is possible to predict the speed of which each participant is performing and navigating during the cognitive task via the intracranial spectral EEG changes (alpha, beta, delta, theta, gamma, and high-gamma) during these tasks. Accuracy of frequency band (brain waves) predicting speed during specific cognitive tasks is measured by how precisely the frequency band predicts navigational speed and is expressed as a percentage of correct prediction. | Participants included patients undergoing intra-cranial EEG monitoring for TLE and are implanted with depth electrodes and microelectrodes. | Posted | Mean | Inter-Quartile Range | percentage of accuracy in decimals | Evaluated for each patient during monitoring period of approximately 2 weeks |
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| 0 |
| 30 |
| 2 |
| 30 |
| 0 |
| 30 |
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| Chronic Inflammatory Reaction | Infections and infestations | Non-systematic Assessment | Study subject had fever of unknown etiology, cerebritis, chronic inflammatory reaction. This was recorded as a serious adverse event that was unrelated to the study procedure. |
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| Title | Measurements |
|---|---|
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| Beta |
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| Gamma |
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| High-gamma |
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