NCT04874220

Brief Summary

The purpose of this study is to understand the neural mechanisms that support real world spatial navigation in humans using deep brain recordings and stimulation during virtual reality (VR), augmented reality, and real world memory tasks. We will determine the cognitive (i.e., memory) and behavioral (i.e., body, head, eye position and movement) factors that modulate deep brain activity and the consequent effects of memory-enhancing deep brain stimulation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 Start

First participant enrolled

September 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

May 15, 2026

Status Verified

July 1, 2025

Enrollment Period

5.8 years

First QC Date

April 28, 2021

Last Update Submit

May 13, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Spatial memory

    Spatial memory will be measured using virtual, augmented and real-world spatial navigation tasks where participants will be asked to navigate a previously learned rout as well as if they recognize objects (i.e. landmarks) that appeared along the route (photos of seen landmarks vs unseen landmarks).

    Throughout study completion, an average of 2-4 days per year

  • Memory performance change

    Memory performance will be measured using excess path length, latency, and accuracy rate.

    Throughout study completion, an average of 2-4 days per year

  • Oscillatory activity change

    Changes in theta, gamma, and theta-gamma coupling will be measured both in relation to changes in memory performance on trials with and without deep brain stimulation as well as in relation to body, head, and eye position in a virtual, augmented, or real-world environment.

    Throughout study completion, an average of 2-4 days per year

Study Arms (1)

RNS Participants

EXPERIMENTAL

Subjects with RNS implants.

Device: Deep Brain StimulationBehavioral: Memory and spatial navigation tasksBehavioral: Physiological SignalsBehavioral: Questionnaires and Assessments

Interventions

Deep brain stimulation will be used

RNS Participants

Tasks may include walking around the room, on a treadmill, or in a controlled environment using VR (virtual reality) or AR (augmented reality) technology designed to simulate real-world navigation. Participants may also use Meta Ray-Ban glasses to capture new memories while recording neural activity.

RNS Participants

Physiological signals such as heart rate, respiration, and skin conductance will be monitored while completing lab tasks. Motion capture and eye-tracking may also be used.

RNS Participants

Participants complete questionnaires and assessments to assess subjective emotional experience.

RNS Participants

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older and has undergone RNS system placement
  • Willing to provide informed consent and participate the study
  • Ability to read and write English fluently

You may not qualify if:

  • Unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Interventions

Deep Brain StimulationSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, OperativeData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nanthia Suthana, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Nanthia Suthana, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Vilchez

CONTACT

Nanthia Suthana, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 5, 2021

Study Start

September 30, 2020

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

May 15, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data collected for this research represent a valuable resource to the scientific community, and the PIs will make them accessible to others, while respecting the special needs for confidentiality. All data will be anonymized before being provided to the scientific community. Researchers can also request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication. The results from the proposed project will also be shared at scientific meetings (local, national and international) as well via published manuscripts.

Time Frame
All data will be provided by the time publication occurs or when the proposed funding period has ended.
Access Criteria
Researchers can request access to the data under collaborative and co- authorship agreements prior to the end of the funding period or before publication.

Locations