Mapping of Human Cognition

NCT ID: NCT05989893

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2027-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Neural recordings and stimulation during language tasks

Group Type: EXPERIMENTAL

Language-based tasks

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Nitin Tandon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nitin Tandon, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nitin Tandon, MD

Role: CONTACT

Nitin.Tandon@uth.tmc.edu

713-500-5456

Eliana M Klier

Role: CONTACT

Eliana.Klier@uth.tmc.edu

713-500-5442

Facility Contacts

Nitin Tandon, MD

Role: primary

Nitin.Tandon@uth.tmc.edu

713-500-5456

Eliana M Klier

Role: backup

Eliana.Klier@uth.tmc.edu

713-500-5442

Other Identifiers

U01NS128921

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-06-0385

Identifier Type: -

Identifier Source: org_study_id