NCT06883981

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Jan 2025

Typical duration 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 Progress41%
Jan 2025Mar 2028

Study Start

First participant enrolled

January 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

March 10, 2025

Last Update Submit

April 3, 2025

Conditions

Keywords

Autobiographical memoryMemoryIEEGEpilepsyReal-World NavigationSpatial MemoryHippocampusMedial Temporal CortexMulti-Modal Recording

Outcome Measures

Primary Outcomes (3)

  • Intracranial EEG power in Theta Band

    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

    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

    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 Outcomes (1)

  • Eye fixation duration to remembered experiences

    4 days

Other Outcomes (1)

  • Questionnaire on Attitudes Regarding Neuroethics

    Day 1

Study Arms (2)

Neuroethical Assessment Group

NO INTERVENTION

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.

Multi-Modal Recording System Assessment Group

EXPERIMENTAL

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.

Behavioral: Free and Cued Recall Memory. Temporal Sequence and Spatial Memory

Interventions

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.

Multi-Modal Recording System Assessment Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Neurosciences Center, University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Alireza Kazemi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 19, 2025

Study Start

January 30, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations