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Analysis of Electrocorticographic Signals

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
working memory and attention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

Only arm of this basic science study, participants will undergo working memory and attention tasks

Outcomes

Primary Outcome Measures

Experiment 1.b. Prioritization cue-related changes in the neural representation of stimuli
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. In this situation, the memory for the face becomes deprioritized, and the primary outcome measure is whether, and if so how, the neural representation changes: does it get weaker? does it disappear altogether? or does it change into a different kind of neural representation?
Experiment 1.b. Prioritization cue-related changes in phase-amplitude coupling
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 associated with a stimulus will change (increase, decrease, change to different frequencies) after that stimulus is prioritized or deprioritized by the cue.
Experiment 3.b. Covert spatial attention-related changes in phase-amplitude coupling
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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2018
Last Updated
September 19, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03785028
Brief Title
Analysis of Electrocorticographic Signals
Official Title
Analysis of Electrocorticographic Signals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this research are to understand how the brain can keep information in mind ("working memory"), and use this information to guide behavior. The two experiments that fall under this study will collect brain signals from epilepsy patients who are having surgery as part of their treatment. More specifically, these signals will be studied from the time while the patient is performing two cognitive tasks.The endpoints are publication of the results from each of the proposed experiments in peer-reviewed journals.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
basic science
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Only arm of this basic science study, participants will undergo working memory and attention tasks
Intervention Type
Behavioral
Intervention Name(s)
working memory and attention
Intervention Description
working memory and attention tasks
Primary Outcome Measure Information:
Title
Experiment 1.b. Prioritization cue-related changes in the neural representation of stimuli
Description
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. In this situation, the memory for the face becomes deprioritized, and the primary outcome measure is whether, and if so how, the neural representation changes: does it get weaker? does it disappear altogether? or does it change into a different kind of neural representation?
Time Frame
Twenty minutes
Title
Experiment 1.b. Prioritization cue-related changes in phase-amplitude coupling
Description
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 associated with a stimulus will change (increase, decrease, change to different frequencies) after that stimulus is prioritized or deprioritized by the cue.
Time Frame
Twenty minutes
Title
Experiment 3.b. Covert spatial attention-related changes in phase-amplitude coupling
Description
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.
Time Frame
Twenty minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Fulvio, PhD
Phone
6082658961
Email
Jacqueline.Fulvio@wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bradley R Postle, PhD
Phone
16083450980
Email
postle@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley R Postle, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Fulvio
Phone
608-265-8961
Email
Jacqueline.Fulvio@wisc.edu
First Name & Middle Initial & Last Name & Degree
Bradley R Postle, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of Electrocorticographic Signals

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