The Neural Code and Dynamics of the Reading Network.

Epilepsy Clinical Trial

Official title:

Comparative Analysis of Structural and Functional Characteristics of Brain Regions Measured by Functional Imaging AND Electrophysiology and Hemispheric Laterality Predicted by Structural Connectivity and Fronto-basal-ganglia Circuits for Selective Stopping and Braking and Diffusion Imaging for Seizure Focus Localization AND Representation and Binding of Spatial and Temporal Episodic Memories in Human Hippocampus AND Sparsity and Spectral-Temporal Decomposition in Real-Time Network Modulation for Intractable Epilepsy AND Neural Basis of Human Spatial Navigation AND Mapping Brain Regions of Mood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989893
• Other study ID #: HSC-MS-06-0385
• Secondary ID: U01NS128921
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: July 31, 2027

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Nitin Tandon, MD
• Phone: 713-500-5456
• Email: Nitin.Tandon[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Tumor
• Epilepsy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in reading errors as assessed by the number of words read incorrectly		Baseline, during stimulation( about 2 seconds after baseline )
Primary	Change in reaction times in milliseconds	reaction time is the time it takes to say the word after seeing it	Baseline, during stimulation( about 2 seconds after baseline )