Modulating Goal-directed Navigation Using Noninvasive Brain Stimulation

NCT05801861 | Recruiting FDA Device

• 1 other identifier: Pro2022000444_17-623R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spatial Navigation

Keywords

transcranial magnetic stimulation; spatial processing; EEG; neuroimaging

Outcome Measures

Primary Outcomes (2)

• Event-related Brain Oscillation: Right Posterior Theta

  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

  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)

Study Arms (4)

Active 10-Hz rTMS

EXPERIMENTAL

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

Active single-pulse rTMS

EXPERIMENTAL

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

Sham 10-Hz rTMS

SHAM COMPARATOR

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

Sham single-pulse rTMS

SHAM COMPARATOR

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

Interventions

Active 10-Hz TMS to the parietal cortex DEVICE

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.

Active 10-Hz rTMS

Active single pulse TMS to the parietal cortex DEVICE

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.

Active single-pulse rTMS

Sham 10-Hz TMS to the right parietal cortex DEVICE

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 10-Hz rTMS

Sham single-pulse rTMS the rigt parietal cortex DEVICE

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 single-pulse rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
• 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).
• History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
• History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University - Newark

Newark, New Jersey, 07102, United States

RECRUITING

MeSH Terms

Conditions

Spatial Navigation; Spatial Processing

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Travis E Baker

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Travis E Baker, PhD

CONTACT

973-353-5485; travis.e.baker@rutgers.edu

Malte Gueth

CONTACT

973-353-3509; mrg217@newark.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) Participants will be blinded to the TMS condition (active or sham)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: March 24, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)