Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05989893

Conditions

Epilepsy

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Language-based tasks

Study Details

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.

Conditions

Epilepsy

Brain Tumor

Study ID

NCT05989893

Start date

Aug 1, 2022

Status verified date

Aug, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Neural recordings and stimulation during language tasks

Interventions

Language-based tasks

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

  • Change in reading errors as assessed by the number of words read incorrectly [ Time Frame: Baseline, during stimulation( about 2 seconds after baseline ) ]
  • Change in reaction times in milliseconds [ Time Frame: Baseline, during stimulation( about 2 seconds after baseline ) ]

Central Contacts and Locations

Central contacts

Nitin Tandon, MD

713-500-5456Nitin.Tandon@uth.tmc.edu

Eliana M Klier

713-500-5442Eliana.Klier@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77479

Contacts

Nitin Tandon, MD

713-500-5456Nitin.Tandon@uth.tmc.edu

Eliana M Klier

713-500-5442Eliana.Klier@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 14, 2026

Last verified

Aug, 2025

Keywords

  • seizure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-14.