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Mapping of Human Cognition

Mapping of Human Cognition

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05989893
Enrollment
75
Registered
2023-08-14
Start date
2022-08-01
Completion date
2028-07-31
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Epilepsy

Keywords

seizure

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.

Interventions

BEHAVIORALLanguage-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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in reading errors as assessed by the number of words read incorrectlyBaseline, during stimulation( about 2 seconds after baseline )
Change in reaction times in millisecondsBaseline, during stimulation( about 2 seconds after baseline )reaction time is the time it takes to say the word after seeing it

Countries

United States

Contacts

CONTACTNitin Tandon, MD
Nitin.Tandon@uth.tmc.edu713-500-5456
CONTACTEliana M Klier
Eliana.Klier@uth.tmc.edu713-500-5442
PRINCIPAL_INVESTIGATORNitin Tandon, MD

The University of Texas Health Science Center, Houston

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026