EpilepsyNCT07226908
Human Thalamus in Propagation of Temporal Lobe Seizures and Memory Formation
A study testing Cognitive experiment and Electrical stimulation of the brain in people with Epilepsy, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Cognitive experiment and Electrical stimulation of the brain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to Aug 2029
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No medical or surgical contraindication to electrode implantation
- Patient capable of understanding the scope of our project or signing informed consent independently
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
- Conditions
- Epilepsy
- Being tested
- Cognitive experiment, Electrical stimulation of the brain
- Keywords
- Intracranial Electroencephalography
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive experimentOther
Record brain activity during memory encoding
Electrical stimulation of the brainOther
Measure accuracy and reaction time during cognitive tasks
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Patients with Thalamic Electrode Implants | Other | Patients will undergo cognitive testing and electrical stimulation experiments. Receives: Other: Cognitive experiment; Other: Electrical stimulation of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebro-cerebral evoked potentials
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).
Measured: During experiment up to 2 weeks
fMRI BOLD activity
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.
Measured: During experiment up to 2 weeks
Epileptogenicity Index (EI)
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.
Measured: During experiment up to 2 weeks
Seizure propagation
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.
Measured: During experiment up to 2 weeks
Coordinated activity across HPC and ANT
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.
Measured: During experiment up to 2 weeks
Cognitive task performance
In total, each patient will be asked to encode 200 words across the 5 sessions.
Measured: During experiment up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start1 Sep 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (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 Stanford UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josef Parvizi, Stanford University
- Investigators
- Josef Parvizi, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226908
- Sponsor's protocol ID
- 11354
- Other IDs
- 1R01NS137650-01A1
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once data collection and analysis for a Specific Aim is complete, we will share our data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Thalamus in Propagation of Temporal Lobe Seizures and Memory Formation
- ClinicalTrials.gov ID
- NCT07226908
- Acronym / sponsor ID
- 11354
- Conditions
- Epilepsy
- Keywords
- Intracranial Electroencephalography
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 12 Nov 2025 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Patients with Thalamic Electrode Implants | Other | Other: Cognitive experiment, Other: Electrical stimulation of the brainPatients will undergo cognitive testing and electrical stimulation experiments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No medical or surgical contraindication to electrode implantation
- Patient capable of understanding the scope of our project or signing informed consent independently
Key exclusion criteria (1 listed)
- Unable to provide informed consent
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 |
|---|---|---|
| Cognitive experimentRecord brain activity during memory encoding | Other | Epilepsy Patients with Thalamic Electrode Implants |
| Electrical stimulation of the brainMeasure accuracy and reaction time during cognitive tasks | Other | Epilepsy Patients with Thalamic Electrode Implants |
Primary outcome
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).
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.
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.
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.
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.
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.
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 12 Nov 2025.
- Individual participant dataSharing planned: Yes. Once data collection and analysis for a Specific Aim is complete, we will share our data.
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Epilepsy
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.
Josef Parvizi, MD PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive experiment and Electrical stimulation of the brain in people with Epilepsy, run by Stanford University 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 12 Nov 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebro-cerebral evoked potentials (time frame: During experiment up to 2 weeks). The study lists 6 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 12 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.