NCT07617506

Brief Summary

This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231. This study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and/or single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress56%
Jun 2025Apr 2027

Study Start

First participant enrolled

June 4, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

May 23, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Neural stimulationMemory disordersWorking MemoryStereo Electroencephalography (SEEG)

Outcome Measures

Primary Outcomes (3)

  • Local field potential changes in response to working memory tasks

    Local field potential changes are from intracranial neural recordings taken while patients complete spatial working memory tasks. In the manual remember 1 remember 2 task, patients are instructed to hold down a cursor on a central location box colored one color or another on screen, while two boxes in locations sequentially flash on screen. Depending on the central location box color, the patient will drag their cursor to the first or second location box shown, after the central box has disappeared from screen. In the retro remember 1 remember 2 task, the color of the central box color is not shown until both location boxes have flashed onscreen. In the manual version, the central location box color is constant throughout the trial.

    During patient's epilepsy monitoring stay, approximately 20-30 minutes

  • Single unit neuronal spiking changes in response to memory tasks

    Single neuron spiking activity is recorded through SEEG micro neural recordings while patients complete working memory tasks.

    During patient's epilepsy monitoring stay, approximately 20-30 minutes

  • Behavioral performance changes with simulation

    Bipolar stimulation through pre-selected SEEG electrodes in the prefrontal cortex and surrounding areas will occur during the remember 1 remember 2 working memory tasks. Stimulation will be performed via the Ripple Neuromed Summit system. Stimulation will be tested with each patient prior to task to determine safety and tolerability, while patient is monitored by a neurosurgeon or neurologist.

    During patient's epilepsy monitoring stay, approximately 20-30 minutes

Study Arms (1)

Epilepsy patients

All participants will be patients with medically refractory epilepsy who have undergone depth electrode placement for stereo EEG monitoring for seizure localization. Participants will complete working memory tasks and EEG recordings will be concurrently collected from their depth electrodes. Some subjects will undergo macro-micro electrode implantation as a part of their SEEG implantation procedure for the purpose of EEG macro (local activity) and micro (single-unit) recordings. Some subjects will complete working memory tasks with stimulation applied during task completion.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with medically refractory epilepsy who have undergone depth electrode placement for localization of their refractory seizures via SEEG monitoring.

You may qualify if:

  • Undergoing SEEG monitoring at Vanderbilt University Medical Center
  • Age \>18
  • English speaking

You may not qualify if:

  • Age \<18
  • Not able to complete questionnaires (unable to comprehend instructions or follow directions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

EEG recordings

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biomedical Engineering, Principal Investigator

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 1, 2026

Study Start

June 4, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations