The Neural Code and Dynamics of the Reading Network.

Trial Title: The Neural Code and Dynamics of the Reading Network.

NCT ID: NCT05989893

Condition: Epilepsy
Brain Tumor

Conditions: Official terms:
Epilepsy

Conditions: Keywords:
seizure

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Language-based tasks
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.
Arm group label: Neural recordings and stimulation during language tasks

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The University of Texas Health Science Center at Houston

Address:
City: Houston
Zip: 77479
Country: United States

Status: Recruiting

Contact:
Last name: Nitin Tandon, MD

Phone: 713-500-5456
Email: Nitin.Tandon@uth.tmc.edu

Contact backup:
Last name: Eliana M Klier

Phone: 713-500-5442
Email: Eliana.Klier@uth.tmc.edu

Start date: August 1, 2022

Completion date: July 31, 2027

Lead sponsor:
Agency: The University of Texas Health Science Center, Houston
Agency class: Other

Collaborator:
Agency: National Institute of Neurological Disorders and Stroke (NINDS)
Agency class: NIH

Source: The University of Texas Health Science Center, Houston

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05989893