EpilepsyNCT05989893
Mapping of Human Cognition
A study testing Language-based tasks in people with Epilepsy and Brain Tumor, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy, Brain Tumor
- What is being tested?
- Language-based tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77479
Nitin Tandon, MD, 713-500-5456, Nitin.Tandon@uth.tmc.edu
Eliana M Klier, 713-500-5442, Eliana.Klier@uth.tmc.edu
About this study
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
- Being tested
- Language-based tasks
- Keywords
- seizure
- Medical subject headings
- Epilepsy, Brain Neoplasms, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language-based tasksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neural recordings and stimulation during language tasks | Experimental | Not described Receives: Behavioral: Language-based tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reading errors as assessed by the number of words read incorrectly
Measured: Baseline, during stimulation( about 2 seconds after baseline )
Change in reaction times in milliseconds
reaction time is the time it takes to say the word after seeing it
Measured: Baseline, during stimulation( about 2 seconds after baseline )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Tandon, The University of Texas Health Science Center, Houston
- Investigators
- Nitin Tandon, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989893
- Sponsor's protocol ID
- HSC-MS-06-0385
- Other IDs
- U01NS128921
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Human Cognition
- ClinicalTrials.gov ID
- NCT05989893
- Acronym / sponsor ID
- HSC-MS-06-0385
- Conditions
- Epilepsy, Brain Tumor
- Keywords
- seizure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural recordings and stimulation during language tasks | Experimental | Behavioral: Language-based tasks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language-based tasksIn 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. | Behavioural | Neural recordings and stimulation during language tasks |
Primary outcome
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 )
reaction time is the time it takes to say the word after seeing it
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Enrolling by invitationPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Tandon, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language-based tasks in people with Epilepsy and Brain Tumor, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Tandon, MD (713-500-5456, Nitin.Tandon@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 )). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.