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Recruiting NCT04874220

Neural Correlates of Real World Spatial Navigation in Humans

No phase Interventional Memory, Delayed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation, Memory and spatial navigation tasks, Physiological Signals, Questionnaires and Assessments.
Who it may be relevant to
Registry conditions: Memory, Delayed. Basic parameters: 12 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Deep Brain Stimulation
    Deep brain stimulation will be used
  • Behavioral Memory and spatial navigation tasks
    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.
  • Behavioral Physiological Signals
    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.
  • Behavioral Questionnaires and Assessments
    Participants complete questionnaires and assessments to assess subjective emotional experience.

Primary outcome measures

  • Spatial memory [Time frame: 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]
  • Oscillatory activity change [Time frame: Throughout study completion, an average of 2-4 days per year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 2 centers
  • University of California, Los Angeles — Los Angeles
  • Duke University — Durham

Identifiers

NCT: NCT04874220 · Pro00117931 · U01NS117838 · R01MH124761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗