NCT06540976

Brief Summary

This project will use intracranial recordings and stimulation of the human brain to understand the unique contributions of the posterior cingulate cortex (PCC) to episodic memory behavior. The goal is to test how distinct subregions of the PCC differentially contribute to memory-based decisions (e.g., have I seen this picture before?). The ability to perform invasive studies of the human brain is through routine clinical monitoring of brain activity which occurs during the neurosurgical treatment of epilepsy. However, this project only focuses on the basic science of PCC and memory behavior. Specifically, the investigators will use single-0cell and population measures of brain activity to test a new theory of PCC function which focuses on the executive processes needed to support memory retrieval and memory-based decisions. By studying the PCC, a convergence zone of memory and executive brain systems, progress can be made in elucidating how the failure to successfully leverage past experiences in daily behavior can occur as a common symptom of both neurodegenerative disease (e.g., Alzheimer's disease) and multiple psychiatric conditions (e.g., schizophrenia) implicating PCC dysfunction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Jan 2023

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress77%
Jan 2023Apr 2027

Study Start

First participant enrolled

January 18, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

April 16, 2024

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Episodic/Executive behavioral task performance accuracy

    Participants will perform three tasks each testing the accuracy of executive (reward) or episodic (memory strength) based decisions. Outcome measures will be decision accuracy (% correct).

    Outcome assessed 10 minutes after intervention

  • Episodic/Executive behavioral task performance speed

    Participants will perform three tasks each testing the speed of executive (reward) or episodic (memory strength) based decisions. Outcome measures will be response/decision reaction time (milliseconds).

    Outcome assessed 10 minutes after intervention

  • Changes in high-frequency electrophysiological brain response

    During behavioral task performance, electrophysiological signals recorded from the brain will be quantified for changes in the mean high-frequency activity (70-150 Hz) amplitude during correct and incorrect episodic/executive decisions. The goal is to track this electrophysiological activity to quantify if and when brain activity in the posterior cingulate cortex occurs during memory and non-memory based decisions.

    Outcome assessed 1 hour after intervention

Study Arms (3)

Experiment 1 - episodic / executive switch

EXPERIMENTAL

All enrolled participants will be asked to perform experiment 1, which is a cognitive task involving the switch between performing episodic memory decisions (e.g., "did you eat fruit yesterday?") and executive decisions (e.g. "...does 5+3+8 = 17?"). Participants will perform this computer-based task while electrical brain activity is recorded from the posterior cingulate cortex, hippocampus and prefrontal cortex. This task takes 18 minutes to complete.

Behavioral: Cognitive testing

Experiment 2 - executive decision task

EXPERIMENTAL

All enrolled participants will be asked to perform experiment 2, which is a cognitive task involving reward-based decisions between two options. For each decision, the two options will differ in their risk and reward (e.g., 100% chance of 10 points vs. 30% chance of 50 points). Participants will perform this computer-based task while electrical brain activity is recorded from the posterior cingulate cortex, hippocampus and prefrontal cortex. This task takes 15 minutes to complete.

Behavioral: Cognitive testing

Experiment 3 - episodic decision task

EXPERIMENTAL

All enrolled participants will be asked to perform experiment 3, which is a cognitive task involving memory-based decisions between two options (pictures of people). For each decision, the two pictures will differ in memory strength and reward (e.g., familiar picture for 10 points vs. unfamiliar picture 50 points). Memory strength for each picture will be defined by how many times the picture was previously shown (e.g., 2 vs. 10 presentations) prior to performing the memory decision task. Participants will perform this computer-based task while electrical brain activity is recorded from the posterior cingulate cortex, hippocampus and prefrontal cortex. This task takes 15 minutes to complete.

Behavioral: Cognitive testing

Interventions

Cognitive tasks testing executive and episodic based decisions, and the switching between these processes.

Experiment 1 - episodic / executive switchExperiment 2 - executive decision taskExperiment 3 - episodic decision task

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants are patients undergoing invasive brain monitoring for epilepsy and will be asked to consent to participation in this basic science protocol (which is focused on the patient group but is not focused on the study of epilepsy).

You may not qualify if:

  • Individuals not undergoing invasive brain monitoring for epilepsy.
  • Individuals outside of the age range (18-50 yrs).
  • Individuals with cognitive impairment or intellectual difficulty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania - Pavilion

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2024

First Posted

August 7, 2024

Study Start

January 18, 2023

Primary Completion (Estimated)

March 2, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Data will be shared through the National Institute of Mental Health Data Archive (NIMH NDA).

Shared Documents
ANALYTIC CODE

Locations