Trial Outcomes & Findings for Electrophysiological Biomarkers in MTLE Patients. (NCT NCT04710004)
NCT ID: NCT04710004
Last Updated: 2024-03-05
Results Overview
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.
TERMINATED
NA
1 participants
Baseline, up to 6 weeks postintervention
2024-03-05
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrophysiological Biomarkers in MTLE Patients.
Baseline characteristics by cohort
| Measure |
Brain Stimulation Via Clinically Implanted Electrodes
n=1 Participants
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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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, up to 6 weeks postinterventionPopulation: No data collected. Subject was discharged before testing could be completed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, up to 6 weeks postinterventionPopulation: No data collected. Subject was discharged before testing could be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, up to 6 weeks postinterventionPopulation: No data collected. Subject was discharged before testing could be completed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Brain Stimulation Via Clinically Implanted Electrodes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place