Mesial Temporal Lobe Epilepsy
Conditions
Keywords
Epilepsy, Biomarkers
Brief summary
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.
Detailed description
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).
Interventions
DEVICEAsynchronous 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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Male or female, aged 18-65 3. Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring 4. Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays
Exclusion criteria
1. Any patient who is unwilling or unable to provide consent 2. Women who are pregnant 3. Patients under 18 years 4. Incarcerated persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intracranial EEG Recording: Spectral Power From Baseline | Baseline, up to 6 weeks postintervention | 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. |
| Change in Intracranial EEG Recording: Synchrony From Baseline | Baseline, up to 6 weeks postintervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Memory During Brain Stimulation From Baseline | Baseline, up to 6 weeks postintervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Brain Stimulation Via Clinically Implanted Electrodes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: Baseline, up to 6 weeks postintervention
Population: No data collected. Subject was discharged before testing could be completed.
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.
Time frame: Baseline, up to 6 weeks postintervention
Population: No data collected. Subject was discharged before testing could be completed.
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.
Time frame: Baseline, up to 6 weeks postintervention
Population: No data collected. Subject was discharged before testing could be completed.