- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03785028
Analysis of Electrocorticographic Signals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are 2 separate experiments proposed, both of which use repeated-measures designs.
1: Electrocorticography (ECoG) study of visual working memory. Each trial from the behavioral task will start by presenting subjects with two visual images, one each from two of these three categories: faces, words, and outdoor scenes. They will then be cued as to which one they'll be tested on with a recognition probe, and after the first probe the cuing-probing process is repeated. Patients selected for this study will have depth electrodes implanted in the left medial temporal lobe and/or grids covering left occipital, temporal, and/or parietal cortex, and suitability of a patient's data for the final dataset will require that a minimum of one stimulus category can be decoded from them. (The precise minimum number of trials required cannot be calculated a priori, because this requires knowing the signal-to-noise ratio in a dataset, a property that is highly variable in electrocorticography data.)
2. Electrocorticography of spatial selective attention. Each trial from the behavioral task will start by presenting subjects with a white "+" on a screen, with each arm pointing to a potential target location. During each 92-trial block of trials, only two 180-degree opposing locations will ever be cued, with one arm of the "+" turning yellow and the opposing one turning blue, to indicate with 75% validity the location at which an oriented Gabor patch will appear (5 degrees from fixation; cue color mapping counterbalanced), requiring a speeded "R/L" tilt judgment. Orthogonal to cue-color configuration, half of the trials in each block will begin with presentation of an "x" that will rotate by 45 degrees with an unpredictable lag (.5 sec +/- .3). On these trials, the cue-to-target interval (i.e., from rotation to "+" to color-cue onset) will be 750 msec. On trials that begin with the onset of a "+", cue-to-target interval will vary unpredictably between 650, 750, and 850 msec. Decomposition of alpha-band oscillations (brain waves cycling at roughly 10 times per second) into components associated with each location will be derived by filtering the whole-scalp signal with weights from the inverted encoding model trained to encode the four critical locations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants with implanted electrode arrays who are willing to participate and able to cooperate and follow research instructions will be recruited.
- Must be able to read
- Must be able to name objects
- Must be able to articulate thoughts with spoken language
Exclusion Criteria:
- post-operative pain requiring narcotics
- repeated seizures clouding consciousness
- IQ of 85 and below
- post-operative subdural bleeding
- cerebral pathology affecting the cortical regions from which recordings are made
- women who are pregnant, or who think they may be pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Arm
Only arm of this basic science study, participants will undergo working memory and attention tasks
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working memory and attention tasks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Qualitative Measure: Prioritization Cue-related Changes in the Neural Representation of Stimuli Reported as Binary for Prioritized and Unprioritized Item Decodability
Time Frame: Twenty minutes
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This experiment will use a machine learning analysis -- multivariate pattern classification -- to "decode" the brain signals measured by the electrocorticography electrodes.
That is, the analysis will determine if the face/word/scene that is being remembered is being represented by these particular brain signals).
The primary outcome will be to assess what happens to the neural representation of, say, a face, when the patient is probed that the other stimulus presented on that trial will be tested first - i.e., the analysis will assess the decodability of the two items as a function of their priority for upcoming task demands.
Reported here is the categorical performance of Support Vector Machines (SVMs) trained using a 10-fold cross-validation procedure to decode the prioritized and unprioritized memory items (faces, scenes, or words).
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Twenty minutes
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Qualitative Measure: Working Memory Delay Period Phase-amplitude Coupling Reported as Direction (Increase/Decrease) for Region and Stimulus Type
Time Frame: Twenty minutes
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Phase-amplitude coupling (PAC) refers to the synchrony between low frequency oscillations and bursts of high-frequency signal, which is interpreted as a proxy for neuronal firing.
The primary outcome measure is whether the level of phase-amplitude coupling associated with a stimulus will change (increase, decrease, change to different frequencies) after that stimulus is prioritized or deprioritized by the cue.
Reported here is the direction of PAC between low theta oscillations (6 Hz) and high-gamma bursts (>140 Hz) in binary terms according to whether the PAC increased or decreased for the three stimulus types (faces, scenes, or words) in electrode signals analyzed in different brain regions.
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Twenty minutes
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Experiment 3.b. Covert Spatial Attention-related Changes in Phase-amplitude Coupling
Time Frame: Twenty minutes
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Phase-amplitude coupling refers to the synchrony between low frequency oscillations and bursts of high-frequency signal, which is interpreted as a proxy for neuronal firing.
The primary outcome measure is whether the level of phase-amplitude coupling in tissue representing a region of space that is irrelevant for an entire block of trials will change in a manner that mirrors the dynamic changes expected for each trial's uncued location, or whether it will be insensitive to shifts of attention that are, by definition, never relevant for that tissue over the course of that block of trials.
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Twenty minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bradley R Postle, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0282
- A538900 (Other Identifier: UW Madison)
- SMPH\PSYCHIATRY\PSYCHIATRY (Other Identifier: UW Madison)
- Protocol Version 6/18/2019 (Other Identifier: UW Madison)
- 2R01MH095984 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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