Capturing Autobiographical Memory Formation in Real World Spaces Using Multimodal Recordings

NCT ID: NCT06883981

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy Autobiographical Memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Free and Cued Recall Memory. Temporal Sequence and Spatial Memory

Intervention Type BEHAVIORAL

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.

Interventions

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Free and Cued Recall Memory. Temporal Sequence and Spatial Memory

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Cory Inman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Neurosciences Center, University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alireza Kazemi, PhD

Role: CONTACT

5303040970

Facility Contacts

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Cory S Inman, PhD

Role: primary

801-581-8939

Other Identifiers

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1R61MH135109-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00183967

Identifier Type: -

Identifier Source: org_study_id

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