Recruiting

Hippocampal Activity

Sponsor:

NYU Langone Health

Code:

NCT07224191

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Visual Exploration

Ambulatory Exploration

Study Details

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.

Conditions

Epilepsy

Study ID

NCT07224191

Start date

Feb 25, 2026

Status verified date

Jul, 2026

Completion date

Oct 8, 2028

Anticipated

Primary completion date

Oct 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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
  • MMSE>=24

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 generalized tonic-clonic or other seizure with potential to fall or cause injury per month
  • Able to walk and wear research equipment without assistance
  • MMSE>=24

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 within the last week

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 Design

Enrollment

56 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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).

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).

Interventions

Visual Exploration

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

Ambulatory Exploration

Series of cognitive tasks completed during a study visit.

Primary outcome measure

  • Hippocampal Theta Power Under High Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Hippocampal Theta Power Under Medium Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Hippocampal Theta Power Under Low Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Hippocampal Theta Power Under No Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Coherence Time-Locked to the Saccade Under High Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Coherence Time-Locked to the Saccade Under Medium Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Coherence Time-Locked to the Saccade Under Low Cognitive Loads [ Time Frame: Study Visit (Day 1) ]
  • Coherence Time-Locked to the Saccade Under No Cognitive Loads [ Time Frame: Study Visit (Day 1) ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-08.