- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874220
Neural Correlates of Real World Spatial Navigation in Humans
May 13, 2026 updated by: Duke University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriela Vilchez
- Phone Number: 9196812577
- Email: suthanalab@duke.edu
Study Contact Backup
- Name: Nanthia Suthana, PhD
- Phone Number: 9196812577
- Email: suthanalab@duke.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- Recruiting
- University of California, Los Angeles
-
Contact:
- Sonja Hiller
- Phone Number: 310-794-7517
- Email: shiller@mednet.ucla.edu
-
Principal Investigator:
- Nanthia Suthana, PhD
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Recruiting
- Duke University
-
Contact:
- Gabriela Vilchez
- Phone Number: 919-681-2577
- Email: suthanalab@duke.edu
-
Principal Investigator:
- Nanthia Suthana, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 12 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
Exclusion Criteria:
- Unwilling to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RNS Participants
Subjects with RNS implants.
|
Deep brain stimulation will be used
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.
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.
Participants complete questionnaires and assessments to assess subjective emotional experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spatial memory
Time Frame: Throughout study completion, an average of 2-4 days per year
|
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
Time Frame: Throughout study completion, an average of 2-4 days per year
|
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
Time Frame: Throughout study completion, an average of 2-4 days per year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nanthia Suthana, PhD, University of California, Los Angeles
- Principal Investigator: Nanthia Suthana, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
April 28, 2021
First Submitted That Met QC Criteria
April 30, 2021
First Posted (Actual)
May 5, 2021
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Surgical Procedures, Operative
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Electric Stimulation Therapy
- Surveys and Questionnaires
- Deep Brain Stimulation
Other Study ID Numbers
- Pro00117931 (Duke University)
- R01MH124761 (U.S. NIH Grant/Contract)
- U01NS117838 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
All data will be provided by the time publication occurs or when the proposed funding period has ended.
IPD Sharing 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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