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

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2020

Longer than P75 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 Progress97%
Sep 2020Jun 2026

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

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5.8 years

First QC Date

April 28, 2021

Last Update Submit

July 22, 2025

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

Interventions

Deep brain stimulation will be used

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 (1)

University of California Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Nanthia Suthana, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 5, 2021

Study Start

September 30, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 23, 2025

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