- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07224191
Hippocampal Oscillations During Exploration
Human Hippocampal Oscillations During Visuomotor Exploration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1 - Visual Exploration in Surgical Patients Investigators will study 20 surgical patients with high-resolution intracranial EEG (iEEG) to investigate hippocampal activity during visual exploration. Participants will view between 10-15 panoramic environments using Meta Quest AR/VR glasses while their eye movements and head turns are tracked. Eye-tracking, head-turn, and iEEG data will be synchronized with visual stimuli, and intracranial EEG and single-unit data will be analyzed for changes in neuronal firing and brain activity before and after saccades.
Aim 2 - Ambulatory Exploration in RNS Patients and Healthy Controls Investigators will study 12 epilepsy patients with implanted responsive neurostimulator (RNS) devices and 24 healthy controls (HCs) during real-world exploration. Participants will walk through and explore visually distinct rooms while wearing synchronized high-density EEG (hdEEG), eye-tracking glasses, and body position sensors. Data from hippocampal iEEG, hdEEG, eye tracking, and motion sensors will be synchronized offline to examine brain-behavior relationships and the influence of cognitive load on saccade-hippocampal interactions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anli Liu, MD, MA
- Phone Number: (929) 455-2323
- Email: Anli.Liu@nyulangone.org
Study Contact Backup
- Name: Ayelet Rosenberg
- Phone Number: (646) 558-0893
- Email: Ayelet.rosenberg@nyulangone.org
Study Locations
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New York
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New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All subjects:
- Adults (18-70 years)
- Able to provide informed consent
Aim 1: Surgical epilepsy patients' inclusion criteria
- Implanted hippocampal depth electrodes for Stage 1 epilepsy surgery
- IQ=>80*
Aim 2: RNS patients Inclusion criteria
- Implanted RNS device with at least one hippocampal depth electrode
- At least 5 months post-implantation to avoid the post-implant effect
- Have a relatively low number of seizures, defined as =<1 debilitating seizure per week
- Able to walk and wear research equipment without assistance
- IQ>=80
Aim 2: Healthy Control Inclusion criteria • Able to walk and wear research equipment without assistance
Exclusion Criteria:
RNS patients, Aim 2:
• Any generalized tonic-clonic seizure(s) within the last year
All subjects:
- Legally blind
- Smoking tobacco, marijuana, recreational drugs or alcohol use within 1 week of cognitive testing
- Unable to give informed consent
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Epilepsy Surgery Patients
Aim 1: Participants will be presented with between 10-15 unique immersive virtual environments (depending on patient tolerance) for patients to explore using VR glasses.
Control tasks will be run to account for eye movements during non-navigation.
For recording eye movements in darkness during REM sleep, as part of a control task, 4 electrodes will be placed above and below both eyes, a standard technique in polysomnographic studies.
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Cognitive testing while admitted to the epilepsy monitoring unit (number of sessions will vary depending on patient availability and stamina).
|
|
Experimental: Patients with RNS Devices
Aim 2: Participants will walk between 4-6 rooms within an office floor.
Each office will contain generic objects (office furniture, computers, lighting) and unique objects (artwork, photographs, books, and personal items).
As control conditions, subjects will first be asked to walk around and between two empty rooms under different lighting conditions and speeds.
Participants will also be asked to participate in all awake saccade control conditions (without a visual cognitive load).
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Series of cognitive tasks completed during a study visit.
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Experimental: Healthy Control Participants
Aim 2: Participants will walk between 4-6 rooms within an office floor.
Each office will contain generic objects (office furniture, computers, lighting) and unique objects (artwork, photographs, books, and personal items).
As control conditions, subjects will first be asked to walk around and between two empty rooms under different lighting conditions and speeds.
Participants will also be asked to participate in all awake saccade control conditions (without a visual cognitive load).
|
Series of cognitive tasks completed during a study visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hippocampal Theta Power Under High Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. High cognitive loads defined as visual exploration of a complex scene with goal-driven task.
|
Study Visit (Day 1)
|
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Hippocampal Theta Power Under Medium Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. Medium cognitive loads defined as visual exploration of a simpler scene with fewer objects.
|
Study Visit (Day 1)
|
|
Hippocampal Theta Power Under Low Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. Low cognitive loads defined as visual exploration of moving dots.
|
Study Visit (Day 1)
|
|
Hippocampal Theta Power Under No Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. Low cognitive loads defined as staring at a blank field of view or REM sleep.
|
Study Visit (Day 1)
|
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Coherence Time-Locked to the Saccade Under High Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. High cognitive loads defined as visual exploration of a complex scene with goal-driven task.
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Study Visit (Day 1)
|
|
Coherence Time-Locked to the Saccade Under Medium Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. Medium cognitive loads defined as visual exploration of a simpler scene with fewer objects.
|
Study Visit (Day 1)
|
|
Coherence Time-Locked to the Saccade Under Low Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. Low cognitive loads defined as staring at a blank field of view or REM sleep.
|
Study Visit (Day 1)
|
|
Coherence Time-Locked to the Saccade Under No Cognitive Loads
Time Frame: Study Visit (Day 1)
|
Aims 1 and 2. Low cognitive loads defined as staring at a blank field of view or REM sleep.
|
Study Visit (Day 1)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anli Liu, MD, MA, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-01119
- R61DC022830-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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