Capturing Autobiographical Memory Formation in Real World Spaces Using Multimodal Recordings (CAPTURE)

April 3, 2025 updated by: Cory Inman, University of Utah

Capturing Autobiographical Memory Formation in People Moving Through Real-World Spaces Using Synchronized Wearables and Intracranial Recordings of EEG

The goal of this observational study is to develop novel methods for integrating multimodal data streams with invasive neural recordings to study autobiographical memory (AM) formation in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) for epilepsy treatment. The main questions it aims to answer are:

How does the brain encode and retrieve real-world autobiographical memories? Can multimodal data integration enhance our understanding of memory-related cognitive and neural mechanisms?

Participants will:

  • Use a smartphone-based recording application (CAPTURE app) to collect real-world data.
  • Have their wearable sensor data (e.g., audio-visual, accelerometry, GPS, autonomic physiology, eye tracking) synchronized with invasive neural recordings.

Researchers will analyze these multimodal data streams to develop new analytic approaches for studying memory formation in naturalistic settings, with the long-term goal of informing neuromodulation-based memory enhancement treatments for individuals with memory disorders.

Study Overview

Detailed Description

This observational study aims to develop and validate novel methodologies for integrating multimodal data streams with invasive neural recordings in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) undergoing treatment for epilepsy. The study focuses on understanding the neural mechanisms underlying autobiographical memory (AM) formation and retrieval in real-world settings. By leveraging real-time, ecologically valid data collection, this research seeks to bridge the gap between controlled laboratory-based memory studies and naturalistic memory processes.

Study Design and Data Collection Participants with implanted neurostimulation devices will use a smartphone-based application (CAPTURE) to log real-world experiences while wearing additional sensors to record behavioral, physiological, and environmental data.

The study integrates multiple data modalities, including:

  • Neural recordings from implanted neurostimulation devices
  • Wearable sensor data, including:
  • Audio-visual recordings
  • GPS location tracking
  • Accelerometry for movement analysis
  • Autonomic physiology measurements (e.g., heart rate, skin conductance)
  • Eye-tracking data

By synchronizing these data streams, researchers will establish a high-fidelity representation of autobiographical memory encoding and retrieval processes in daily life.

Analytic Methods and Data Integration

This study aims to develop computational frameworks for real-time data alignment and analysis. The primary methodological goals include:

  • Temporal synchronization of multimodal data with neural recordings
  • Automated feature extraction from behavioral and physiological data
  • Neural signal processing techniques to identify patterns of activity associated with memory formation and retrieval
  • Development of machine learning models to predict successful memory encoding and recall based on neural and behavioral signals
  • These analytic advancements will enable researchers to assess memory-related brain activity in naturalistic environments, providing insights into the neural correlates of real-world autobiographical memory.

Potential Impact:

The findings from this study have significant implications for neuroscience, cognitive psychology, and clinical applications. By establishing methods for naturalistic neural recording and analysis, this research paves the way for neuromodulation-based memory enhancement therapies for individuals with memory disorders, including those with epilepsy, traumatic brain injury, and neurodegenerative diseases. The study also advances real-world cognitive neuroscience, enabling a deeper understanding of how the brain supports memory outside of laboratory settings.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • Clinical Neurosciences Center, University of Utah
        • Contact:

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

Yes

Study Population

Patients with epilepsy with Neuropace RNS implants. Healthy participants (without epilepsy).

Description

Inclusion Criteria:

  • 18 years of age or older
  • healthy to minor cognitive impairment

Exclusion Criteria:

  • younger than 18 years of age
  • more than minor cognitive impairment

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Neuroethical Assessment Group
Patients with epilepsy who have Neuropace RNS implants who will be surveyed about the neuroethics of real-world multi-modal recordings to assess their attitude toward research data sharing and confidentiality.
Experimental: Multi-Modal Recording System Assessment Group
Patients with epilepsy who have Neuropace RNS implants, and patients without epilepsy/RNS implants, who will participate in real-world navigation and autobiographical memory tasks in order to evaluate the reliability and signal quality of the multi-modal recording system.
Memory for real-world episodic experiences will be tested in the laboratory first with free recall (spoken narration of their recollections from each environment) and then with cued recall, in which participants will be cued with an event image from the CAPTURE app, a map location, or a relative time and asked to recall the other two non-cued pieces of episodic information (event, place, or time). Because we will know the 'ground truth', the cued recall test will allow us to measure how accurately the participant is able to remember key details of each episode. We will also assess temporal order memory by asking participants to arrange 1st person images in the order in which they occurred, and we will assess spatial memory by asking them to place each image on a schematic map of the venue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial EEG power in Theta Band
Time Frame: 4 days
iEEG power in the theta band between 4-8 Hz, will be assessed to identify the real-world experience features that contribute to changes in this important neural power band for memory encoding.
4 days
Intracranial EEG power in Gamma Band
Time Frame: 4 days
iEEG power in the gamma band between 30-100 Hz, will be assessed to identify the real-world experience features that contribute to changes in this important neural power band for memory encoding.
4 days
Intracranial EEG normalized aperiodic exponent
Time Frame: 4 days
This feature of intracranial EEG will be assessed as a broadband state-level change in brain activity during the participant's real-world experiences.
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye fixation duration to remembered experiences
Time Frame: 4 days
Using eye-tracking, we will use the duration in time participants fixate on remembered experiences as a measure of visual attention.
4 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire on Attitudes Regarding Neuroethics
Time Frame: Day 1
This is a survey for people with responsive neurostimulation (RNS) devices. We ask some general demographic information. Then we will ask questions about how patients feel about the sharing of various types of personal data and how much they care about privacy.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

January 30, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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