Epilepsy Clinical Trial
Official title:
Modulating Oscillations and Working Memory in Patients With Subdural Electrodes
Purpose: The purpose of this pilot study is to investigate the dynamics between theta and alpha oscillations in the control of working memory. These findings will be informative of what types of brain stimulation are most effective at modulating brain activity. Deep brain stimulation and transcranial magnetic stimulation are used for an increasing number of neurological and psychiatric disorders. Participants: Eligible participants are patients who have previously had electrodes implanted to monitor epilepsy (outside of research activity). 50 participants will be recruited, 25 participants for each phase of the study. Procedures (methods): The participants will perform a cognitive control task. During the task, rhythmic trains of direct cortical stimulation will be delivered to the frontal cortex alone or to the frontal and parietal cortex. Electrocorticography will be collected concurrent with stimulation.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Able to provide informed consent - History of medically intractable epilepsy - Speak and understand English - For the stimulation session, the participant must have electrodes in the relevant locations Exclusion Criteria: - Current diagnosis of other neurological illnesses including ischemic stroke, intracerebral hemorrhage, brain neoplasm - Major systemic illness - Severe cognitive impairment - diagnosed by clinician in neuropsychiatric evaluation - Severe psychiatric illness - Excessive use of alcohol or other substances - Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
Alagapan S, Lustenberger C, Hadar E, Shin HW, Fr?hlich F. Low-frequency direct cortical stimulation of left superior frontal gyrus enhances working memory performance. Neuroimage. 2019 Jan 1;184:697-706. doi: 10.1016/j.neuroimage.2018.09.064. Epub 2018 Sep 27. — View Citation
Alagapan S, Riddle J, Huang WA, Hadar E, Shin HW, Frohlich F. Network-Targeted, Multi-site Direct Cortical Stimulation Enhances Working Memory by Modulating Phase Lag of Low-Frequency Oscillations. Cell Rep. 2019 Nov 26;29(9):2590-2598.e4. doi: 10.1016/j.celrep.2019.10.072. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Working Memory Task Performance - Pashler's working memory capacity metric (k) | The participant will be presented with three colored squares in both visual fields during a practice session. Then the participant is presented with an informative retro-cue, an arrow to the left or right, that is 100% predictive of the upcoming probe, or an uninformative neural cue, an arrow pointing in both directions. Finally, in the probe epoch participants are presented with an array of squares on the left or the right side of the screen. Participants must determine if the array of colored squares is the same or different from those held in memory. Performance will be defined as: k=N*(HR*FA)/(1-FA) where N is the number of the items that are held in memory. HR is the hit rate defined as the percent correct for trials where the probe does not match the encoding array. FA is the false alarm rate defined as the percent incorrect for trials where the probe does match the encoding array. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period | |
Primary | Change in Working Memory Task Performance - Reaction Time | The participant will be presented with three colored squares in both visual fields during a practice session. Then the participant is presented with an informative retro-cue, an arrow to the left or right, that is 100% predictive of the upcoming probe, or an uninformative neural cue, an arrow pointing in both directions. Finally, in the probe epoch participants are presented with an array of squares on the left or the right side of the screen. Participants must determine if the array of colored squares is the same or different from those held in memory. Reaction times will be quantified in milliseconds. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period | |
Primary | Intracranial EEG Multi-taper fft | Time-frequency analysis of electrophysiology data will be performed using methods like multi-taper fft. This will be compared between sham (arrhythmic) and stimulation trials to identify if stimulation enhances neuronal entrainment. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period | |
Primary | Intracranial EEG weighted phase lag index (wPLI) | Functional connectivity will be measured using weighted phase lag index (WPLI). To calculate WPLI, first Morlet wavelet convolution is performed to extract instantaneous phase and amplitude for the frequency of interest for the two target sites. Next, the cross-spectral density is calculated (one signal multiplied by the complex conjugate of the other). From the cross-spectral density the imaginary component of the resulting signal is extracted. Then those imaginary values are averaged over the time frame of instance (here, the second half of the stimulation train). Finally, the magnitude of the resulting vector is taken to be the wPLI. This metric quantifies the consistency of phase lag between the two target regions and is weighted towards signals with a 90 or 270 degree offset to address a common confound in electrophysiology, volume conduction. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period | |
Secondary | Intracranial EEG Wavelets | Spectral analysis and functional connectivity analysis of electrophysiology data will be performed using methods like wavelets. This will be compared between sham (arrhythmic) and stimulation trials to identify if stimulation enhances neuronal entrainment. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period | |
Secondary | Intracranial EEG phase locking | Spectral analysis and functional connectivity analysis of electrophysiology data will be performed using methods like phase locking. This will be compared between sham (arrhythmic) and stimulation trials to identify if stimulation enhances neuronal entrainment. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period | |
Secondary | Intracranial EEG Granger causality | Spectral analysis and functional connectivity analysis of electrophysiology data will be performed using methods like Granger causality. This will be compared between sham (arrhythmic) and stimulation trials to identify if stimulation enhances neuronal entrainment. | During the 1- to 1.5-hour test at Baseline and Stimulation Session conducted over a 1 to 2 day period |
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