Brain Stimulation and Visually-guided Navigation

NCT04961645 | Terminated Results FDA Device

• 2 other identifiers: STUDY000025125R01EY029724
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the neural mechanisms causally involved in how people navigate through their immediately visible environment (e.g., walking around one's bedroom flawlessly and effortlessly, not bumping into the walls or furniture). To investigate whether particular neural mechanisms are causally involved in "visually-guided navigation", repetitive transcranial magnetic stimulation (rTMS) is used to temporarily disrupt the functioning of particular brain regions in healthy adults while they are shown simple visual stimuli of places (e.g., bedrooms, kitchens, and living rooms) and asked to perform simple computer tasks or to complete simple behavioral tasks.

Conditions

Healthy Participants

Keywords

Visually-guided navigation

Outcome Measures

Primary Outcomes (4)

• Accuracy During Visually-guided Navigation Computer-based Task

  To assess performance during the visually-guided navigation computer-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. While participants are shown simple visual stimuli of places (e.g., bedrooms, kitchens, and living rooms) they are asked to perform simple computer-based tasks (e.g., imagine they are walking through the room, and respond via button press whether they can leave through a door on the left, center, or right wall, as indicated by a continuous path on the floor). Performance is measured in task accuracy (the percentage of tasks performed correctly). A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

  During rTMS of control site and during rTMS of OPA, on Day 1

• Reaction Time During Visually-guided Navigation Computer-based Task

  To assess performance during the visually-guided navigation computer-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. While participants are shown simple visual stimuli of places (e.g., bedrooms, kitchens, and living rooms) they are asked to perform simple computer-based tasks (e.g., imagine they are walking through the room, and respond via button press whether they can leave through a door on the left, center, or right wall, as indicated by a continuous path on the floor). Performance is measured in the time (in milliseconds) that it takes to complete the task correctly. A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

  During rTMS of control site and during rTMS of OPA, on Day 1

• Accuracy During Visually-guided Navigation Behavioral-based Task

  To assess performance during the visually-guided navigation behavior-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. Participants are asked to complete simple behavioral-based tasks (e.g., actually walk around a small room and search for hidden objects). Performance is measured in task accuracy (the percentage of tasks performed correctly). A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

  During rTMS of control site and during rTMS of OPA, on Day 1

• Reaction Time During Visually-guided Navigation Behavioral-based Task

  To assess performance during the visually-guided navigation behavioral-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. Participants are asked to complete simple behavioral tasks (e.g., actually walk around a small room and search for hidden objects). Performance is measured as the time (in milliseconds) that it takes to complete the task correctly. A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

  During rTMS of control site and during rTMS of OPA, on Day 1

Study Arms (2)

Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task

EXPERIMENTAL

Participants receiving rTMS while they perform computer-based tests to examine the causal involvement of OPA in visually-guided navigation. The study visit lasts approximately 90 minutes.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Computer-based Test

Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task

EXPERIMENTAL

Participants receiving rTMS while they perform behavioral-based tests to examine the causal involvement of OPA in visually-guided navigation. The study visit lasts approximately 90 minutes.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Behavioral-based Test

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

TMS is a safe and noninvasive method for affecting brain function relying on the properties of electromagnetic induction. Action potentials are triggered in neurons, along with a subsequent period of deactivation. Normal ongoing brain activity is disrupted providing a way for investigators to produce a transient and reversible period of brain disruption.

Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task; Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task

Computer-based Test BEHAVIORAL

Participants will be seated comfortably in a chair and asked to complete a simple computer-based task where they imagine walking through a room and press a button indicating if they can leave through a door on the left, center, or right wall. During or just before each of these tasks, participants will receive rTMS. In rTMS, a small plastic coil is placed next to the participant's head. The coil will be placed over the relevant brain region identified during the participant's fMRI scan. The coil will then generate a magnetic pulse, and stimulation will occur.

Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task

Behavioral-based Test BEHAVIORAL

Participants will be asked to complete a simple behavioral task that will require them to walk around in a small room and search for hidden objects. During or just before each of these tasks, participants will receive rTMS. In rTMS, a small plastic coil is placed next to the participant's head. The coil will be placed over the relevant brain region identified during the participant's fMRI scan. The coil will then generate a magnetic pulse, and stimulation will occur.

Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal or corrected-to-normal vision

You may not qualify if:

• Metal in the body
• Personal or first-degree family history of epileptic seizure
• A known brain injury
• Claustrophobia
• Taking certain medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline) or reduce the effects of rTMS, such as benzodiazepines
• Adults who are unable to consent, pregnant women, and prisoners

Sponsors & Collaborators

• Emory University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Daniel Dilks, PhD
• Organization: Emory University

dilks@emory.edu

404-727-2980

Study Officials

• Daniel Dilks, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The computer-based task study arm will occur first prior to enrolling participants into the behavioral-based task study arm.

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: March 3, 2023
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)