NCT03785028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2021

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

December 14, 2018

Results QC Date

February 8, 2024

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Qualitative Measure: Prioritization Cue-related Changes in the Neural Representation of Stimuli Reported as Binary for Prioritized and Unprioritized Item Decodability

    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).

    Twenty minutes

  • Qualitative Measure: Working Memory Delay Period Phase-amplitude Coupling Reported as Direction (Increase/Decrease) for Region and Stimulus Type

    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.

    Twenty minutes

  • 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.

    Twenty minutes

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Behavioral: working memory and attention

Interventions

working memory and attention tasks

Experimental Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

Study underpowered for meaningful results. Working memory tasks prove challenging for this patient population, leading to unreliable or uninterpretable data. Recruitment challenges related to coverage of data recording, and cognitive ability requirements, are prevalent in this patient population leading to small number of data sets collected and analyzed.

Results Point of Contact

Title
Brad Postle, PhD
Organization
University of Wisconsin - Madison

Study Officials

  • Bradley R Postle, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: basic science
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 24, 2018

Study Start

July 19, 2019

Primary Completion

February 21, 2021

Study Completion

February 21, 2021

Last Updated

May 1, 2024

Results First Posted

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations