Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT06883981

Conditions

Epilepsy

Autobiographical Memory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Free and Cued Recall Memory. Temporal Sequence and Spatial Memory

Study Details

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.

Conditions

Epilepsy

Autobiographical Memory

Study ID

NCT06883981

Start date

Jan 30, 2025

Status verified date

Apr, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Intracranial EEG power in Theta Band [ Time Frame: 4 days ]
  • Intracranial EEG power in Gamma Band [ Time Frame: 4 days ]
  • Intracranial EEG normalized aperiodic exponent [ Time Frame: 4 days ]

Central Contacts and Locations

Central contacts

Alireza Kazemi, PhD

5303040970alireza.kazemi@utah.edu

Locations

Clinical Neurosciences Center, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Cory S Inman, PhD

801-581-8939inmanneurolab@gmail.com

More Information

Sponsor

University of Utah

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Keywords

  • Autobiographical memory
  • Memory
  • IEEG
  • Epilepsy
  • Real-World Navigation
  • Spatial Memory
  • Hippocampus
  • Medial Temporal Cortex
  • Multi-Modal Recording

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-04-08.