Modulating Goal-directed Navigation Using Noninvasive Brain Stimulation

November 14, 2025 updated by: Travis Baker, PhD, Rutgers, The State University of New Jersey

Modulating Spatial Processing During Goal-directed Navigation Using Transcranial Magnetic Stimulation

Our specific aim is to examine the effects of TMS on spatial processing during goal-directed navigation. In these experiments the investigators will utilize a scalp-recorded brain oscillation called right posterior theta that is believed to index the sensitivity of the parahippocampal cortex to spatial context. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in virtual navigation tasks, and if so, whether it would affect the spatial encoding of rewards and subsequent choices during task performance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The design is primarily a randomized control-trial design (3 sessions), testing the effects of 10-Hz rTMS and single-pulse TMS on spatial processing during goal-directed navigation tasks. Subjects will be randomly assigned to an active or sham group. All participants will be asked to complete two TMS sessions within two weeks. For the active TMS group, participants will be scanned using a 3 Tesla MRI system and will receive a structural (T1) and diffusion-weighted imaging (DWI) scan (Session A). For each subsequent TMS session, the TMS coil will be placed 1cm above the scalp over a right parietal region displaying maximum connectivity patterns with the parahippocampal cortex. Subjects will be randomly assigned to a 10-Hz rTMS protocol or single-pulse TMS protocol. At the start of the first TMS session (Session B), participants will be fitted with an EEG cap and engage in a virtual T-maze reward task. In this task, subjects will be asked to choose the left or right alley of the maze, and after their response, they will received a reward stimulus (apple or orange) which will indicate whether the participant will receive 5 or 0 cents on that trial. For the 10-Hz group, the task will be divided into 2 blocks (225 trials per block). At the start of Block 1, the robotic arm will position the TMS coil <1 cm over the right parietal target. Next, 50 rTMS pulses will be delivered at 110% of participants' rMT at 10-Hz continuously over the target immediately before every 10 trials of the T-maze. A total of 2250 pulses will be delivered and 450 T-maze trials completed. For the single-pulse group, the T-maze task will be divided into 2 blocks (225 trials per block). For the first block, a single TMS pulse will be delivered at 110% of participants' rMT over the TMS target immediately following trial-to-trial feedback and at the peak phase of the evoked theta oscillations (closed-loop). Following 10 trials of single-pulse, subjects will complete 5 trials with no TMS (total 150 TMS trials, 75 no-TMS trials). For the second block, a single TMS pulse will be delivered over the TMS target immediately following trial-to-trial feedback and at the trough phase of the evoked theta oscillation (peak and trough order will be counterbalanced across subjects). Following 10 trials of single-pulse, subjects will complete 5 trials with no TMS (total 150 TMS trials, 75 no-TMS trials). A total of 300 TMS trials and 150 no-TMS trials of the T-maze task will be performed. At the end of Session B, participants will be scheduled to return to the laboratory to complete Session C on a separate day. At the start of the second TMS session (Session C), participants will be fitted with an EEG cap and engage in the Linear Track Maze. During the encoding phase of this task, subjects will be presented with five distinct landmarks (pillars) along the track. Each time they reach a landmark, they stop for 500 ms and an apple (a reward, 5 cents) or an orange (no reward, 0 cents) appears. Only one landmark is associated with a reward. Following the encoding phase, the recall phase starts and subjects are shown both old and new landmarks. Subjects are instructed to indicate via button press which of these pillars was accompanied by a reward and earn the reward by correctly identifying the reward pillar. Recall performance will be assessed using d-prime, which represents how well subjects were able to recall the correct reward location. In total, subjects perform 200 trials across four blocks (50 trials each), resulting in a duration of roughly 30 minutes. For each block of the encoding phase, a single TMS pulses will be delivered at either at the peak, trough, ascending, descending phase of the evoked theta oscillation following the onset of the reward stimulus. (phase target order will be counterbalanced across blocks and subjects). The investigators will then test the effect of phase stimulation on recall performance as assed using d-prime. Identical protocols will be applied to the Sham groups with the exception that the TMS coil will be targeted at electrode position P4 and flipped 180 degrees, preventing pulses from hitting the scalp.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be between the ages of 18 and 55 years old.
  2. Not received substance abuse treatment within the previous 30 days.
  3. Be in stable mental and physical health.
  4. If female, test non-pregnant.
  5. No evidence of focal or diffuse brain lesion on MRI.
  6. Be willing to provide informed consent.
  7. Be able to comply with protocol requirements and likely to complete all study procedures.

Exclusion Criteria:

  1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
  2. Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy).
  3. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
  4. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
  5. Life time history of mental disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.

uninterruptable central nervous system medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active 10-Hz rTMS
For the first TMS session, participants will receive 10-Hz repetitive TMS (rTMS) delivered at 110% of participants' resting motor threshold over the predefined parietal target for a total of 2250 pulses. For the second TMS session, participants will receive single pulse TMS during the phase target of each task trial and delivered at 110% of participants' resting motor threshold over the predefined parietal target for a total of 200 pulses.
Device: Active 10-Hz TMS to the parietal cortex
The active 10-Hz TMS group will receive 10hz TMS stimulation in the first TMS session, and single pulse TMS in the second TMS session. Participants in the active stimulation group will receive 10-Hz TMS to right parietal cortex. The TMS target will be based on subject specific anatomical MRI images (diffusion imaging). TMS will be delivered using a robotic neuronavigation system (Smartmove, ANT). Stimulation intensity will be standardized at 110% of RMT and adjusted to the skull to cortical surface based on e-field calculations (simnibs). Stimulation will be delivered to the right parietal cortex using an active/placebo figure-8 coil, an magventure TMS device.
Experimental: Active single-pulse rTMS
For the first TMS session, participants will receive a single TMS pulse during the phase target of each task trial and delivered at 110% of participants' resting motor threshold over the predefined parietal target for a total of 300 pulses. For the second TMS session, participants will receive single pulse TMS during the phase target of each task trial and delivered at 110% of participants' resting motor threshold over the predefined parietal target for a total of 200 pulses.
Device: Active single pulse TMS to the parietal cortex
The active single pulse TMS group will receive single pulse TMS stimulation in the first and second TMS session. Participants in the active stimulation group will receive single pulse TMS to right parietal cortex. The TMS target will be based on subject specific anatomical MRI images (diffusion imaging). TMS will be delivered using a robotic neuronavigation system (Smartmove, ANT). Stimulation intensity will be standardized at 110% of RMT and adjusted to the skull to cortical surface based on e-field calculations (simnibs). Stimulation will be delivered to the right parietal cortex using an active/placebo figure-8 coil, an magventure TMS device.
Sham Comparator: Sham 10-Hz rTMS
Identical parameters of the active 10-Hz rTMS group will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.
Device: Sham 10-Hz TMS to the right parietal cortex
The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
Sham Comparator: Sham single-pulse rTMS
Identical parameters of the active single-pulse rTMS group will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.
Device: Sham single-pulse rTMS the rigt parietal cortex
The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event-related Brain Oscillation: Right Posterior Theta
Time Frame: Day 0 (day of testing)
Right posterior theta (RPT: 4-8 hz) is a scalp recorded brain oscillation sensitive to spatial processing of reward stimulus presented during navigation tasks. RPT will be measured during the presentation of the reward stimulus (Reward, No-reward) during virtual navigation. A time-frequency analysis will be used to measure RPT power for each electrode by averaging the single-trial EEG according to feedback type (reward and no-reward) during the navigation tasks. The size of the RPT will be determined by identifying the maximum amplitude of the RPT response and evaluated at posterior electrodes. The RPT will be measured for each proposed right posterior target across active and sham groups, and used to measure the efficacy of the TMS target to modulate brain activity associated with spatial processing.
Day 0 (day of testing)
Spatial Recall performance
Time Frame: Day 0 (day of testing)
Spatial recall performance learning will be measured using the Linear Track maze. During an initial encoding phase participants are exposed to five pairs of distinct pillars (landmarks), and only one of the pillar location will be paired with a reward cue. Then during the recall phase, participants are presented with old and new landmarks, and must recall which landmark contained the reward. A correct response would result in a 5-cent reward. Recall performance will be assessed using d-prime, which is calculated as the normalized distance between the probability distributions of the hit rate and the false alarm rate. This parameter represents how well subjects were able to maximize correct hits while minimizing false alarms. High recall performance is measured as a subject's ability to correctly identify rewarded pillars and reject non-rewarded pillars, as well as pillars that were not present during the last trial.
Day 0 (day of testing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Travis E Baker, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2022000444_17-623R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data may be uploaded to an open source framework. All data will be deidentified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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