- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961645
Brain Stimulation and Visually-guided Navigation
Brain Stimulation Study of Human Visually-guided Navigation Using Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Overview
Status
Conditions
Detailed Description
Human ability to navigate through the immediately visible environment is crucial for survival. However, the representations and computations underlying this remarkable ability are not well understood, and current computer vision algorithms (robots) still lag far behind human performance. One promising strategy for attempting to understand "visually-guided navigation" is to characterize the neural systems that accomplish it. The results from functional magnetic resonance (fMRI) on adult humans have begun to elucidate the cortical regions involved in visually-guided navigation, with the central finding that there is at least one visual cortical region - called the occipital place area (OPA) that may play a central role in the ability to navigate through currently visible places (e.g., walking around our bedroom flawlessly and effortlessly, not bumping into the walls or furniture our bedroom). However, fMRI is a correlational method, and research still needs to determine if this functionally specific brain region is causally involved in visually-guided navigation. Understanding the causal involvement of this region will provide important clues about how humans navigate their world, and also perhaps someday be harnessed to help those individuals who devastatingly lose the ability to navigate, as a result of eye diseases, brain surgery, stroke, neurodegenerative diseases, or developmental disorders.
The use of rTMS to investigate the causal involvement of particular brain regions in particular human abilities is not novel, having been used to investigate face recognition, scene recognition, and object recognition. The general question for this research is to determine, using rTMS, the causal involvement of OPA in visually-guided navigation.
Participants will have an fMRI scan to identify the OPA location in each individual participant. Once the OPA location is known, participants will receive the rTMS study intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Normal or corrected-to-normal vision
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task
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.
|
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.
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.
|
|
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy During Visually-guided Navigation Computer-based Task
Time Frame: During rTMS of control site and during rTMS of OPA, on Day 1
|
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
Time Frame: During rTMS of control site and during rTMS of OPA, on Day 1
|
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
Time Frame: During rTMS of control site and during rTMS of OPA, on Day 1
|
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
Time Frame: During rTMS of control site and during rTMS of OPA, on Day 1
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Dilks, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- STUDY00002512
- 5R01EY029724 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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