TMS for Spatial Navigation

Overseen By Malte Gueth

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: CNS medications

Disqualifiers: Neurological disorders, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how TMS, a non-invasive brain stimulation technique, affects spatial navigation and decision-making in a virtual environment. Researchers focus on a specific brain signal that aids in understanding spatial context and test whether TMS can alter this signal to influence navigation and decision-making. Participants are divided into groups: some receive real TMS, while others receive a sham (fake) version for comparison. This trial may suit individuals in stable mental and physical health who have not undergone substance abuse treatment in the past month. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on brain function and decision-making.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on uninterruptable central nervous system medication, which might imply some restrictions.

What prior data suggests that TMS is safe for spatial navigation tasks?

A previous study found that using 10-Hz transcranial magnetic stimulation (TMS) on the parietal cortex was generally safe. The most common side effects included mild headaches or scalp discomfort, which were short-lived and typically occurred during the TMS session itself.

Research has also examined single-pulse TMS on the parietal cortex. This type of TMS did not show any harmful effects on brain activity in the study and was well-tolerated, with most participants experiencing it without serious issues.

Both treatments—10-Hz TMS and single-pulse TMS—are being used in this trial. These studies suggest that they are safe, with only minor and temporary side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these TMS treatments for spatial navigation because they offer a novel way to potentially enhance brain function by directly targeting the parietal cortex with precise magnetic pulses. Unlike traditional treatments that may rely on medications affecting the whole brain, TMS focuses on specific brain areas, which could lead to more targeted and potentially faster improvements. The use of different TMS frequencies, such as 10-Hz repetitive pulses and single pulses, offers flexibility in exploring how varying stimulation patterns can affect spatial navigation. This approach could pave the way for advancements in treating cognitive impairments associated with conditions like Alzheimer's disease, where spatial navigation often suffers.

What evidence suggests that this trial's TMS treatments could be effective for spatial navigation?

Research shows that 10-Hz Transcranial Magnetic Stimulation (TMS) can enhance brain functions related to memory and thinking tasks. Studies have found it may boost cognitive performance in conditions like mild cognitive impairment and Alzheimer's disease by stimulating specific brain areas. In this trial, participants will receive either Active 10-Hz TMS or Active single-pulse TMS, both studied for their potential to influence brain signals related to navigation and decision-making. Specifically, research has shown that single-pulse TMS can precisely alter brain activity by targeting specific brain cells, potentially affecting thought processes during tasks. These findings suggest that TMS could effectively improve skills needed for navigation. ^{6 7 8 9 10}

Who Is on the Research Team?

Travis E Baker

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with stable mental and physical health, who haven't had substance abuse treatment in the last month. Participants must not be pregnant, have a history of significant brain disorders or metal implants that affect MRI scans, and should be able to follow study procedures.

Inclusion Criteria

Not received substance abuse treatment within the previous 30 days

No evidence of focal or diffuse brain lesion on MRI

Be willing to provide informed consent

Exclusion Criteria

Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia)

I have a history of autoimmune, endocrine, viral, or vascular brain disorders.

I do not have a history of major neurological issues, head injuries, or any metal implants in my head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo TMS sessions to assess the effects on spatial processing during goal-directed navigation tasks

2 weeks

3 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active 10-Hz TMS to the parietal cortex
• Active single pulse TMS to the parietal cortex
• Sham 10-Hz TMS to the right parietal cortex
• Sham single-pulse rTMS the right parietal cortex
• Sham TMS to the right parietal cortex

Trial Overview The trial tests how Transcranial Magnetic Stimulation (TMS) affects spatial processing during virtual navigation tasks. It compares active TMS pulses against sham (placebo) pulses on the parietal cortex to see if they influence spatial memory and decision-making.

How Is the Trial Designed?

Group I: Active single-pulse rTMS Experimental Treatment 1 Intervention

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.

Group II: Active 10-Hz rTMS Experimental Treatment 1 Intervention

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.

Group III: Sham 10-Hz rTMS Placebo Group 1 Intervention

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.

Group IV: Sham single-pulse rTMS Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Neuronavigated low-frequency rTMS significantly enhances motor-evoked potentials and improves motor behavior, such as reaction time and grip strength, compared to non-navigated rTMS in healthy subjects.

The study involved 10 participants and demonstrated that navigated rTMS leads to more pronounced effects on the contralateral hemisphere, suggesting its potential for better therapeutic outcomes in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuronavigation increases the physiologic and behavioral effects of low-frequency rTMS of primary motor cortex in healthy subjects. Bashir, S., Edwards, D., Pascual-Leone, A.[2022]

A new sham rTMS method was developed that effectively mimics the look, sound, and feel of active rTMS without producing a significant magnetic field, making it suitable for double-blind, placebo-controlled studies.

In tests with naïve subjects, they could not distinguish between active and sham stimulation, indicating the sham method's validity; however, experienced subjects could tell the difference, highlighting the need for careful participant selection in studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sham Transcranial Magnetic Stimulation Using Electrical Stimulation of the Scalp. Mennemeier, M., Triggs, W., Chelette, K., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) at 5 Hz applied to the parietal cortex significantly improved reaction times in a working memory task without affecting accuracy, indicating its potential efficacy for enhancing cognitive performance.

The timing of rTMS application is crucial, as improvements were observed only during the retention phase of the task, suggesting that specific stimulation conditions can optimize working memory performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitation of performance in a working memory task with rTMS stimulation of the precuneus: frequency- and time-dependent effects. Luber, B., Kinnunen, LH., Rakitin, BC., et al.[2019]

Transcranial magnetic stimulation (TMS) of the right parietal cortex impairs visuospatial judgment and alters neural activity in a specific right-hemispheric network, highlighting the role of this network in visuospatial tasks.

The study demonstrates that visuospatial deficits after parietal damage are likely due to disruptions in a broader frontoparietal network rather than just the damaged parietal area, suggesting interconnected brain regions play a crucial role in cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging the brain activity changes underlying impaired visuospatial judgments: simultaneous FMRI, TMS, and behavioral studies. Sack, AT., Kohler, A., Bestmann, S., et al.[2022]

A new TMS 'hunting paradigm' was developed to quickly and reliably identify a specific site over the right anterior intraparietal sulcus (IPS) that can modulate visuospatial behavior, particularly in detecting peripheral gaps in visual tasks.

TMS applied at this identified site can either disrupt or enhance sensitivity to visual stimuli depending on the location of the target, demonstrating the spatial specificity of TMS effects and establishing a method to tailor TMS intensity based on individual motor thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel 'hunting' method using transcranial magnetic stimulation over parietal cortex disrupts visuospatial sensitivity in relation to motor thresholds. Oliver, R., Bjoertomt, O., Driver, J., et al.[2022]

Transcranial magnetic stimulation (TMS) has been effectively used to study the parietal cortex's role in attention and sensorimotor processes, highlighting its high temporal resolution as a key advantage.

Research indicates that specific regions of the parietal cortex are crucial for updating attention and movement representations, particularly when these are redirected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TMS in the parietal cortex: updating representations for attention and action. Rushworth, MF., Taylor, PC.[2022]

In a study involving 100 adult migraine patients, high-rate repetitive transcranial magnetic stimulation (rTMS) significantly reduced headache frequency by 78.7% and severity by 76.6% compared to sham stimulation after one month.

The treatment was found to be safe, with only one patient experiencing transient drowsiness, indicating that rTMS is a promising option for migraine prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. Misra, UK., Kalita, J., Bhoi, SK.[2022]

Different sham transcranial magnetic stimulation (TMS) techniques can produce varying levels of cortical stimulation, with some sham conditions inducing significant brain activity, which could affect trial outcomes.

The study found that a two-wing 45-degree tilt sham condition resulted in only 24% lower voltage than active TMS, indicating that not all sham methods are equally effective in mimicking a true placebo, highlighting the importance of selecting appropriate sham techniques in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sham TMS: intracerebral measurement of the induced electrical field and the induction of motor-evoked potentials. Lisanby, SH., Gutman, D., Luber, B., et al.[2022]

Transcranial magnetic stimulation (TMS) is a non-invasive brain imaging technique that can causally link specific cortical areas to physiological responses, making it more precise than other imaging methods.

Navigated TMS has shown clinical effectiveness in mapping motor areas, assessing recovery after stroke, and treating conditions like depression, but further development of targeting and dosing protocols is needed for improved accuracy and reproducibility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigated transcranial magnetic stimulation. Ruohonen, J., Karhu, J.[2016]

A single pulse of TMS applied to the left parietal cortex disrupted interhemispheric remapping, leading to increased reaction times when subjects had their arms crossed, indicating a significant effect on sensory-motor processing.

Regardless of the TMS location, the study found that TMS generally reduced reaction times, suggesting a non-specific startle reflex effect, but the left parietal TMS specifically impaired the normal processing of sensory information related to arm position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-hemispheric remapping between arm proprioception and vision of the hand is disrupted by single pulse TMS on the left parietal cortex. Fautrelle, L., Gueugnon, M., Barbieri, G., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5691603/

Effects of 10 Hz rTMS on the Neural Efficiency of Working ... This study compared the relative effects of active and sham 10 Hz rTMS applied to dorsolateral prefrontal cortex (DLPFC) on indices of Ne in healthy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306417/

Efficacy and Safety of Transcranial Magnetic Stimulation on ... We aim to analyze the efficacy and safety of TMS on cognition in mild cognitive impairment (MCI), Alzheimer disease (AD), AD-related dementias, and nondementia ...

3. nature.com nature.com/articles/s41386-023-01599-z

Accelerated TMS - moving quickly into the future of ... Accelerated TMS is an emerging application of Transcranial Magnetic Stimulation (TMS) aimed to reduce treatment length and improve response time.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724017804

A preliminary comparison of the clinical efficacy ... To compare the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) under facial feature point (FFP) localization versus neuro-navigated ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.863225/full

Early Improvement Predicts Clinical Outcomes Similarly in ... Our study sought to test the hypothesis that early clinical improvement could predict ultimate treatment response in both iTBS and 10 Hz rTMS patient groups.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10941606/

Online and offline effects of parietal 10 Hz repetitive ... We have found that 3 days of parietal 10 Hz rTMS resulted in offline alpha oscillation entrainment and improved working memory.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4430548/

The Effect of 10 Hz Repetitive Transcranial Magnetic ... High frequency rTMS has been shown to excite, rather than inhibit, the stimulated brain area. However, the bias to the ipsilateral hemifield was ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1041610225002431

Efficacy and safety of transcranial magnetic stimulation on ... The more common and expected adverse effects of TMS are transient headaches, scalp discomfort, and muscle twitches during stimulation (Rossi et al.,2021). In ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1059789/pdf

Repetitive transcranial magnetic Method: We conducted a crossover, randomized, double-blind, sham-controlled clinical study to assess the efficacy and safety of 10Hz rTMS over ...

10. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.108.522144

Safety and Behavioral Effects of High-Frequency Repetitive ... Conclusions— A single session of high-frequency rTMS to the motor cortex was safe. These results require verification with addition of a placebo ...