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The Neural Code and Dynamics of the Reading Network.

Primary Purpose

Epilepsy, Brain Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Language-based tasks
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy focused on measuring seizure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with medically refractory epilepsy who are scheduled to undergo or have previously undergone placement of sub-dural electrodes (including depth electrodes) to localize the site of seizure onset and to map the locations of critical language and motor regions patients with epilepsy, brain tumors or cortically based vascular malformations (cavernous malformations or arterio-venous malformations) with lesions that are/were proximate to crucial brain regions, and who are scheduled to undergo or have previously undergone intra-op mapping of motor, visual or language function, or a Wada test, or maybe part of an awake craniotomy. proficiency in English Exclusion Criteria: Gross structural abnormalities (large hamartomata, tumors, large vascular malformations, very large diffuse malformations of cortical development) that may have impacted upon the location of critical brain areas. Unable to participate in testing due to impaired cognition or mental retardation. Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices Patients with claustrophobia who cannot undergo an MRI scan without sedation

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neural recordings and stimulation during language tasks

Arm Description

Outcomes

Primary Outcome Measures

Change in reading errors as assessed by the number of words read incorrectly
Change in reaction times in milliseconds
reaction time is the time it takes to say the word after seeing it

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
August 4, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05989893
Brief Title
The Neural Code and Dynamics of the Reading Network.
Official Title
Comparative Analysis of Structural and Functional Characteristics of Brain Regions Measured by Functional Imaging AND Electrophysiology and Hemispheric Laterality Predicted by Structural Connectivity and Fronto-basal-ganglia Circuits for Selective Stopping and Braking and Diffusion Imaging for Seizure Focus Localization AND Representation and Binding of Spatial and Temporal Episodic Memories in Human Hippocampus AND Sparsity and Spectral-Temporal Decomposition in Real-Time Network Modulation for Intractable Epilepsy AND Neural Basis of Human Spatial Navigation AND Mapping Brain Regions of Mood
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

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 purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Brain Tumor
Keywords
seizure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Neural recordings and stimulation during language tasks
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Language-based tasks
Intervention Description
In either the MRI suite, or the Epilepsy Monitoring Unit, or the operating room, epilepsy and tumor subjects are asked to perform a variety of language-based tasks as neural recordings are made from and/or neural stimulations are delivered to various language areas of the brain.
Primary Outcome Measure Information:
Title
Change in reading errors as assessed by the number of words read incorrectly
Time Frame
Baseline, during stimulation( about 2 seconds after baseline )
Title
Change in reaction times in milliseconds
Description
reaction time is the time it takes to say the word after seeing it
Time Frame
Baseline, during stimulation( about 2 seconds after baseline )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with medically refractory epilepsy who are scheduled to undergo or have previously undergone placement of sub-dural electrodes (including depth electrodes) to localize the site of seizure onset and to map the locations of critical language and motor regions patients with epilepsy, brain tumors or cortically based vascular malformations (cavernous malformations or arterio-venous malformations) with lesions that are/were proximate to crucial brain regions, and who are scheduled to undergo or have previously undergone intra-op mapping of motor, visual or language function, or a Wada test, or maybe part of an awake craniotomy. proficiency in English Exclusion Criteria: Gross structural abnormalities (large hamartomata, tumors, large vascular malformations, very large diffuse malformations of cortical development) that may have impacted upon the location of critical brain areas. Unable to participate in testing due to impaired cognition or mental retardation. Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices Patients with claustrophobia who cannot undergo an MRI scan without sedation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitin Tandon, MD
Phone
713-500-5456
Email
Nitin.Tandon@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eliana M Klier
Phone
713-500-5442
Email
Eliana.Klier@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin Tandon, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitin Tandon, MD
Phone
713-500-5456
Email
Nitin.Tandon@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Eliana M Klier
Phone
713-500-5442
Email
Eliana.Klier@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Neural Code and Dynamics of the Reading Network.

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