NCT07226908

Brief 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 same individuals (Aim 2), and the effect of ANT and PLV stimulations on memory formation (Aim 3).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
39mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Sep 2024Aug 2029

Study Start

First participant enrolled

September 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

November 12, 2025

Status Verified

August 1, 2025

Enrollment Period

4.9 years

First QC Date

August 11, 2025

Last Update Submit

November 8, 2025

Conditions

Keywords

Intracranial Electroencephalography

Outcome Measures

Primary Outcomes (6)

  • 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).

    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.

    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.

    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.

    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.

    During experiment up to 2 weeks

  • Cognitive task performance

    In total, each patient will be asked to encode 200 words across the 5 sessions.

    During experiment up to 2 weeks

Study Arms (1)

Epilepsy Patients with Thalamic Electrode Implants

OTHER

Patients will undergo cognitive testing and electrical stimulation experiments.

Other: Cognitive experimentOther: Electrical stimulation of the brain

Interventions

Record brain activity during memory encoding

Epilepsy Patients with Thalamic Electrode Implants

Measure accuracy and reaction time during cognitive tasks

Epilepsy Patients with Thalamic Electrode Implants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No medical or surgical contraindication to electrode implantation
  • Patient capable of understanding the scope of our project or signing informed consent independently

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Josef Parvizi, MD PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology and Neurological Sciences (Adult Neurology)

Study Record Dates

First Submitted

August 11, 2025

First Posted

November 12, 2025

Study Start

September 1, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

November 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Once data collection and analysis for a Specific Aim is complete, we will share our data.

Shared Documents
STUDY PROTOCOL
Time Frame
Within 2 years

Locations