Memory, DelayedNCT04874220
Neural Correlates of Real World Spatial Navigation in Humans
A study testing Deep Brain Stimulation, Memory and spatial navigation tasks and Physiological Signals in people with Memory, Delayed, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory, Delayed
- What is being tested?
- Deep Brain Stimulation, Memory and spatial navigation tasks and Physiological Signals
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Gabriela Vilchez, 9196812577, suthanalab@duke.edu
Nanthia Suthana, PhD
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90024
Sonja Hiller, 3107947517, shiller@mednet.ucla.edu
Nanthia Suthana, PhD
About this study
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.
- Conditions
- Memory, Delayed
- Being tested
- Deep Brain Stimulation, Memory and spatial navigation tasks, Physiological Signals, Questionnaires and Assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep brain stimulation will be used
Memory and spatial navigation tasksBehavioural
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 SignalsBehavioural
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.
Questionnaires and AssessmentsBehavioural
Participants complete questionnaires and assessments to assess subjective emotional experience.
| Study group | Role | What they receive |
|---|---|---|
| RNS Participants | Experimental | Subjects with RNS implants. Receives: Device: Deep Brain Stimulation; Behavioral: Memory and spatial navigation tasks; Behavioral: Physiological Signals; Behavioral: Questionnaires and Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Throughout study completion, an average of 2-4 days per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start30 Sep 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory, DelayedStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nanthia Suthana, PhD, Principal investigator, University of California, Los AngelesNanthia Suthana, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874220
- Sponsor's protocol ID
- Pro00117931
- Other IDs
- U01NS117838, R01MH124761
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Real World Spatial Navigation in Humans
- ClinicalTrials.gov ID
- NCT04874220
- Acronym / sponsor ID
- Pro00117931
- Conditions
- Memory, Delayed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Mental Health (NIMH)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RNS Participants | Experimental | Device: Deep Brain Stimulation, Behavioral: Memory and spatial navigation tasks, Behavioral: Physiological Signals, Behavioral: Questionnaires and AssessmentsSubjects with RNS implants. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationDeep brain stimulation will be used | Device | RNS Participants |
| Memory and spatial navigation tasksTasks 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. | Behavioural | RNS Participants |
| Physiological SignalsPhysiological 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. | Behavioural | RNS Participants |
| Questionnaires and AssessmentsParticipants complete questionnaires and assessments to assess subjective emotional experience. | Behavioural | RNS Participants |
Primary outcome
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nanthia Suthana, PhD principal investigator
University of California, Los Angeles
Nanthia Suthana, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation, Memory and spatial navigation tasks and Physiological Signals in people with Memory, Delayed, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Halvorsen, PhD (9196812577, suthanalab@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial memory (time frame: Throughout study completion, an average of 2-4 days per year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.