ClinicalTrials.gg
RecruitingNCT05989893Updated Nov 2, 2026

Mapping of Human Cognition

An interventional study of Language-based tasks in Epilepsy and Brain Tumor, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2022, registered Jul 2023).
  • Started Aug 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy
  • Brain Tumor

Keywords

  • seizure
03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's planned enrollment of 75 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with medically 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Neural recordings and stimulation during language tasks

    Behavioral: Language-based tasks

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.

06

What researchers measure

Primary outcomes

  1. Change in reading errors as assessed by the number of words read incorrectly

    Time frame: Baseline, during stimulation( about 2 seconds after baseline )

  2. Change in reaction times in milliseconds

    reaction time is the time it takes to say the word after seeing it

    Time frame: Baseline, during stimulation( about 2 seconds after baseline )

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05989893
Responsible party
Nitin Tandon (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Aug 14, 2023
Start date
Aug 1, 2022
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Nitin Tandon, MD
Contact
Nitin.Tandon@uth.tmc.edu
713-500-5456
Eliana M Klier
Contact
Eliana.Klier@uth.tmc.edu
713-500-5442
Nitin Tandon, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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