NCT04620928

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

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

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

November 3, 2020

Last Update Submit

January 31, 2023

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

  • Brain activity

    Electrocorticographic brain activity measured from brain surface

    Recorded immediately during experiment

Study Arms (1)

Concept Retrieval

EXPERIMENTAL

Patients will be given behavioral intervention, and their brain activity recorded.

Behavioral: Concepts

Interventions

ConceptsBEHAVIORAL

Images and sounds that are characteristic of various common objects.

Concept Retrieval

Eligibility Criteria

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

You may qualify if:

  • Clinically determined to require an awake left temporal resection of a brain lesion with concurrent language testing.
  • English as a first language.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Gross, MD, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Present a behavioral intervention to a single group of participants and measure subsequent electrical activity in the brain.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

August 2, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)