Healthy ParticipantsNCT04961645
Brain Stimulation and Visually-guided Navigation
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Computer-based Test and Behavioral-based Test in people with Healthy Participants, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), Computer-based Test and Behavioral-based Test
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2023to 17 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal or corrected-to-normal vision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Stimulation Study of Human Visually-guided Navigation Using Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Computer-based Test, Behavioral-based Test
- Keywords
- Visually-guided navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Computer-based TestBehavioural
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.
Behavioral-based TestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Behavioral-based Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During rTMS of control site and during rTMS of OPA, on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start3 Mar 2023
- Primary completion17 May 2023
- Study completion17 May 2023
Why it stopped: The study was terminated in February 2025 after interim analyses among participants in the computer-based task study arm showed that the rTMS was not a successful method of evaluating involvement of OPA in visually-guided navigation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The computer-based task study arm will occur first prior to enrolling participants into the behavioral-based task study arm.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Daniel Dilks, Emory University
- Investigators
- Daniel Dilks, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961645
- Sponsor's protocol ID
- STUDY00002512
- Other IDs
- 5R01EY029724
- Status last verified
- Apr 2025
- First submitted
- 5 Jul 2021
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Stimulation Study of Human Visually-guided Navigation Using Repetitive Transcranial Magnetic Stimulation (rTMS)
- ClinicalTrials.gov ID
- NCT04961645
- Acronym / sponsor ID
- STUDY00002512
- Conditions
- Healthy Participants
- Keywords
- Visually-guided navigation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated in February 2025 after interim analyses among participants in the computer-based task study arm showed that the rTMS was not a successful method of evaluating involvement of OPA in visually-guided navigation.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The computer-based task study arm will occur first prior to enrolling participants into the behavioral-based task study arm.
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Computer-based TestParticipants 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. |
| Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Behavioral-based TestParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal or corrected-to-normal vision
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)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. | Device | Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task, Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task |
| Computer-based TestParticipants 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. | Behavioural | Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task |
| Behavioral-based TestParticipants 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. | Behavioural | Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Dilks, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Computer-based Test and Behavioral-based Test in people with Healthy Participants, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy During Visually-guided Navigation Computer-based Task (time frame: During rTMS of control site and during rTMS of OPA, on Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.