Recruiting

Observational Study

Sponsor:

Boston University Charles River Campus

Code:

NCT05406349

Conditions

Epilepsy Intractable

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Self-navigation task

Observation task

Study Details

Brief summary:

Spatial navigation is a fundamental human behavior, and deficits in navigational functions are among the hallmark symptoms of severe neurological disorders such as Alzheimer's disease. Understanding how the human brain processes and encodes spatial information is thus of critical importance for the development of therapies for affected patients. Previous studies have shown that the brain forms neural representations of spatial information, via spatially-tuned activity of single neurons (e.g., place cells, grid cells, or head direction cells), and by the coordinated oscillatory activity of cell populations. The vast majority of these studies have focused on the encoding of self-related spatial information, such as one's own location, orientation, and movements. However, everyday tasks in social settings require the encoding of spatial information not only for oneself, but also for other people in the environment. At present, it is largely unknown how the human brain accomplishes this important function, and how aspects of human cognition may affect these spatial encoding mechanisms. This project therefore aims to elucidate the neural mechanisms that underlie the encoding of spatial information and awareness of others. Specifically, the proposed research plan will determine how human deep brain oscillations and single-neuron activity allow us to keep track of other individuals as they move through our environment. Next, the project will determine whether these spatial encoding mechanisms are specific to the encoding of another person, or whether they can be used more flexibly to support the encoding of moving inanimate objects and even more abstract cognitive functions such as imagined navigation. Finally, the project will determine how spatial information is encoded in more complex real-world scenarios, when multiple information sources (e.g., multiple people) are present. To address these questions, intracranial medial temporal lobe activity will be recorded from two rare participant groups: (1) Participants with permanently implanted depth electrodes for the treatment of focal epilepsy through responsive neurostimulation (RNS), who provide a unique opportunity to record deep brain oscillations during free movement and naturalistic behavior; and (2) hospitalized epilepsy patients with temporarily implanted intracranial electrodes in the epilepsy monitoring unit (EMU), from whom joint oscillatory and single-neuron activity can be recorded.

Conditions

Epilepsy Intractable

Study ID

NCT05406349

Start date

Aug 6, 2022

Status verified date

Jul, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between 18 and 70 years of age
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Have undergone depth electrode placement for the purpose of epilepsy evaluation/treatment OR have NeuroPace RNS System implanted for epilepsy treatment

Exclusion Criteria:

  • All DSM-V Axis I and II disorders other than nicotine-dependence
  • History of brain damage

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Electrophysiological recordings in participants with intracranially implanted electrodes

All participants will perform behavioral tasks that test their spatial navigation and memory performance in self-navigation and observation tasks.

Interventions

Self-navigation task

Participants will perform a self-navigation task with two experimental conditions: Either they will be asked to walk towards a visible wall-mounted sign, or they will be asked to find and learn a hidden target location within the experimental room.

Observation task

Participants will sit on a chair in a corner of the room (RNS participants) or watch a video that was recorded from the corner of the room (EMU participants). They will be asked to keep track of another person's location who is walking around the room, and to press a button whenever the other person crosses a previously-learned target location.

Primary outcome measure

  • Oscillatory power [ Time Frame: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant) ]
  • Oscillatory amplitude [ Time Frame: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant) ]
  • Oscillatory frequency [ Time Frame: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant) ]
  • Firing rate of single neurons [ Time Frame: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant) ]

Central Contacts and Locations

Central contacts

Matthias Stangl, PhD

617-353-0879mstangl@bu.edu

Locations

Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Jul 27, 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 Boston University Charles River Campus on 2026-07-27.