Back to resultsDefining the Neural Dynamics of Concept Retrieval Using Electrocorticography
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Concepts
Sponsored by
About this trial
This is an interventional basic science trial for Aphasia
Eligibility Criteria
Inclusion Criteria:
- Clinically determined to require an awake left temporal resection of a brain lesion with concurrent language testing.
- English as a first language.
Exclusion Criteria:
- Significant preoperative neuropsychological deficits in memory or naming.
- Patients with inability to make decisions regarding their participation in this research project.
- Surgeon does not plan to expose the area of interest or determines that recording during the resection will interfere with his surgical plan.
Sites / Locations
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Concept Retrieval
Arm Description
Patients will be given behavioral intervention, and their brain activity recorded.
Outcomes
Primary Outcome Measures
Brain activity
Electrocorticographic brain activity measured from brain surface
Secondary Outcome Measures
Full Information
NCT ID
NCT04620928
First Posted
November 3, 2020
Last Updated
January 31, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT04620928
Brief Title
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography
Official Title
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
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
This study will look at the way activity within the brain changes over time while a person is trying to think about certain everyday concepts. To measure brain activity accurately, we will be using electrodes placed on people's brains during awake brain surgery.
Detailed Description
This study will measure the dynamics of cortical activity among early modal cortex and multimodal cortical regions during conceptual retrieval using electrocorticography. Participants will be patients undergoing awake temporal lobe craniotomies. During the surgery patients will have multiple high-density grids placed to simultaneously record activity in multiple areas while the patient is performing language tasks. Activity in each of these regions will be tested for timing differences and informational directionality to determine the temporal dynamics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Present a behavioral intervention to a single group of participants and measure subsequent electrical activity in the brain.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concept Retrieval
Arm Type
Experimental
Arm Description
Patients will be given behavioral intervention, and their brain activity recorded.
Intervention Type
Behavioral
Intervention Name(s)
Concepts
Intervention Description
Images and sounds that are characteristic of various common objects.
Primary Outcome Measure Information:
Title
Brain activity
Description
Electrocorticographic brain activity measured from brain surface
Time Frame
Recorded immediately during experiment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically determined to require an awake left temporal resection of a brain lesion with concurrent language testing.
English as a first language.
Exclusion Criteria:
Significant preoperative neuropsychological deficits in memory or naming.
Patients with inability to make decisions regarding their participation in this research project.
Surgeon does not plan to expose the area of interest or determines that recording during the resection will interfere with his surgical plan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gross, MD, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography
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