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Lack of funding to secure effort for testing.
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The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.
This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain stimulation via clinically implanted electrodes | Experimental | Brain will be stimulated in different patterns including synchronized or asynchronous current. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device | Device | Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intracranial EEG Recording: Spectral Power From Baseline | Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome. | Baseline, up to 6 weeks postintervention |
| Change in Intracranial EEG Recording: Synchrony From Baseline | Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation [-1 to 1] between two time series. The investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome. | Baseline, up to 6 weeks postintervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Memory During Brain Stimulation From Baseline | Patients will be asked to recall a list of words after a 20-second delay in which they will do simple math problems to ensure long-term memory encoding. Three ~1-2-hour sessions will be performed; each session will consist of 24 free recall tasks (12 during ADMES and 12 with no stimulation). The memory score will be assessed as the percentage correct out of 12. The higher the percentage recalled, the better the score. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gross, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epilepsy monitoring unit (EMU) at Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brain Stimulation Via Clinically Implanted Electrodes | Brain will be stimulated in different patterns including synchronized or asynchronous current. Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brain Stimulation Via Clinically Implanted Electrodes | Brain will be stimulated in different patterns including synchronized or asynchronous current. Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Intracranial EEG Recording: Spectral Power From Baseline | Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome. | No data collected. Subject was discharged before testing could be completed. | Posted | Baseline, up to 6 weeks postintervention |
|
Up to 16 days
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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 | Brain Stimulation Via Clinically Implanted Electrodes | Brain will be stimulated in different patterns including synchronized or asynchronous current. Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Gross | Emory University | 404-727-2354 | rgross@emory.edu |
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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 | Sep 9, 2021 | Jan 12, 2024 | Prot_SAP_000.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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|
| Baseline, up to 6 weeks postintervention |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in Intracranial EEG Recording: Synchrony From Baseline | Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation [-1 to 1] between two time series. The investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome. | No data collected. Subject was discharged before testing could be completed. | Posted | Baseline, up to 6 weeks postintervention |
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| Secondary | Changes in Memory During Brain Stimulation From Baseline | Patients will be asked to recall a list of words after a 20-second delay in which they will do simple math problems to ensure long-term memory encoding. Three ~1-2-hour sessions will be performed; each session will consist of 24 free recall tasks (12 during ADMES and 12 with no stimulation). The memory score will be assessed as the percentage correct out of 12. The higher the percentage recalled, the better the score. | No data collected. Subject was discharged before testing could be completed. | Posted | Baseline, up to 6 weeks postintervention |
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