Hippocampal Oscillations During Exploration

NCT ID: NCT07224191

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-10-08

Brief Summary

The objective of this study is to determine how visuomotor exploration relates to hippocampal activity along its long axis. The study will investigate the neurophysiological mechanisms in the hippocampus during (1) visual exploration in surgical patients using high-resolution iEEG, and (2) ambulatory exploration in patients implanted with RNS devices.

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Visual Exploration

Intervention Type: OTHER

Cognitive testing while admitted to the epilepsy monitoring unit (number of sessions will vary depending on patient availability and stamina).

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).

Group Type: EXPERIMENTAL

Ambulatory Exploration

Intervention Type: OTHER

Series of cognitive tasks completed during a study visit.

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).

Group Type: EXPERIMENTAL

Ambulatory Exploration

Intervention Type: OTHER

Series of cognitive tasks completed during a study visit.

Interventions

Visual Exploration

Cognitive testing while admitted to the epilepsy monitoring unit (number of sessions will vary depending on patient availability and stamina).

Intervention Type: OTHER

Ambulatory Exploration

Series of cognitive tasks completed during a study visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

All subjects:

• Adults (18-70 years)
• Able to provide informed consent

• Implanted hippocampal depth electrodes for Stage 1 epilepsy surgery
• IQ=>80*

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anli Liu, MD, MA

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Central Contacts

Anli Liu, MD, MA

Role: CONTACT

Anli.Liu@nyulangone.org

(929) 455-2323

Ayelet Rosenberg

Role: CONTACT

Ayelet.rosenberg@nyulangone.org

(646) 558-0893

Other Identifiers

R61DC022830-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-01119

Identifier Type: -

Identifier Source: org_study_id