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Neural Correlates of Real World Spatial Navigation in Humans

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ClinicalTrials.gov Identifier: NCT04874220
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Nanthia Suthana, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Memory, Delayed Device: Deep Brain Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Neural Correlates of Real World Spatial Navigation in Humans
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory


Intervention Details:
  • Device: Deep Brain Stimulation
    Deep brain stimulation will be used


Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 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
  • Not a native English Speaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874220


Contacts
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Contact: Sonja Hiller 3107947517 shiller@mednet.ucla.edu

Locations
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United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Sonja Hiller    310-794-7517    shiller@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Nanthia Suthana, PhD University of California, Los Angeles
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Responsible Party: Nanthia Suthana, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04874220    
Other Study ID Numbers: 20-001459
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes