- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07226908
Human Thalamus in Propagation of Temporal Lobe Seizures and Memory Formation
November 8, 2025 updated by: Josef Parvizi, Stanford University
The goal of the study is to examine how two key subregions of the human thalamus (ANT and PLV) are connected with other brain structures (Aim 1), how seizures involve the two thalamic subregions differently and how the map of cortico-thalamic ictal propagation matches the intrinsic connectivity maps identified in the same individuals (Aim 2), and the effect of ANT and PLV stimulations on memory formation (Aim 3).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Stanford, California, United States, 94304
- Stanford Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- No medical or surgical contraindication to electrode implantation
- Patient capable of understanding the scope of our project or signing informed consent independently
Exclusion Criteria:
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Epilepsy Patients with Thalamic Electrode Implants
Patients will undergo cognitive testing and electrical stimulation experiments.
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Record brain activity during memory encoding
Measure accuracy and reaction time during cognitive tasks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebro-cerebral evoked potentials
Time Frame: During experiment up to 2 weeks
|
To map thalamocortical and corticothalamic causal effective connectivity, the study team will use the well-known method of repeated single electrical pulse stimulation with intracranial EEG.
Study team will measure the amplitude and timing to first peak of cerebro-cerebral evoked potentials (CCEPs).
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During experiment up to 2 weeks
|
|
fMRI BOLD activity
Time Frame: During experiment up to 2 weeks
|
To map thalamocortical and corticothalamic functional connectivity, he study team will obtain 8 runs of 6mins resting state fMRIs.
Study team will measure the correlation of BOLD activity across voxels of interest.
|
During experiment up to 2 weeks
|
|
Epileptogenicity Index (EI)
Time Frame: During experiment up to 2 weeks
|
The study team will identify seizure onset zones (SOZs) using the measure of Epileptogenicity Index (EI) applied to data collected through intracranial EEG, and will label the SOZs as medial temporal lobe epilepsy (mTLE) versus nonmedial TLEs.
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During experiment up to 2 weeks
|
|
Seizure propagation
Time Frame: During experiment up to 2 weeks
|
Seizure propagation to ANT and PLV will be examined through intracranial EEG data within individuals by measuring EI and the propagation latencies from SOZ to ANT and PLV recording sites will be noted.
|
During experiment up to 2 weeks
|
|
Coordinated activity across HPC and ANT
Time Frame: During experiment up to 2 weeks
|
Successful memory encoding is associated with coordinated activity across hippocampus (HPC) and ANT (i.e., high frequency activity in ANT locked to the phase of hippocampal theta).
Using intracranial EEG data, the study team will follow traditional analyses of changes in power in the canonical EEG bands (e.g., 3-7 Hz, theta band, 40-150 Hz, high gamma, etc.) as well as computationally derived aperiodic features of the signal [i.e., using the fitting oscillations & one over f (FOOOF) function].
Response onset latency of neural activity will determine with simultaneous recordings across HPC, ANT, and PLV how each ROI is engaged in time during a given experimental condition (i.e., encoding trials later recalled and trials not later recalled).
We will also use validated methods of phase amplitude coupling (PAC) and intersite phase coherence (ISPC) to quantify cross regional relationships.
|
During experiment up to 2 weeks
|
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Cognitive task performance
Time Frame: During experiment up to 2 weeks
|
In total, each patient will be asked to encode 200 words across the 5 sessions.
|
During experiment up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Josef Parvizi, MD PhD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Study Registration Dates
First Submitted
August 11, 2025
First Submitted That Met QC Criteria
November 8, 2025
First Posted (Actual)
November 12, 2025
Study Record Updates
Last Update Posted (Actual)
November 12, 2025
Last Update Submitted That Met QC Criteria
November 8, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11354 (DAIDS ES)
- 1R01NS137650-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Once data collection and analysis for a Specific Aim is complete, we will share our data.
IPD Sharing Time Frame
Within 2 years
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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