- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620928
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography
January 31, 2023 updated by: William L Gross, MD PhD, Medical College of Wisconsin
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: Concept Retrieval
Patients will be given behavioral intervention, and their brain activity recorded.
|
Images and sounds that are characteristic of various common objects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity
Time Frame: Recorded immediately during experiment
|
Electrocorticographic brain activity measured from brain surface
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Recorded immediately during experiment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Gross, MD, PhD, Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2021
Primary Completion (Actual)
January 31, 2023
Study Completion (Actual)
January 31, 2023
Study Registration Dates
First Submitted
November 3, 2020
First Submitted That Met QC Criteria
November 3, 2020
First Posted (Actual)
November 9, 2020
Study Record Updates
Last Update Posted (Actual)
February 1, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00038561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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