Transcranial Magnetic Stimulation for Brain Network Targeting

(NetworkTMS Trial)

Overseen By Lipeng Ning, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pacemaker, Claustrophobia, Neurosurgery, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Transcranial Magnetic Stimulation (TMS) to determine its effectiveness in improving brain function, specifically targeting areas involved in thinking and decision-making. Researchers will use MRI scans to identify optimal brain regions for TMS stimulation. Participants will take a computer-based test to assess whether TMS helps them respond faster and make fewer mistakes. This trial suits individuals without neurological disorders or metal implants who can undergo MRI scans and TMS sessions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research in brain function improvement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcranial magnetic stimulation is safe for brain network targeting?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally well-tolerated. TMS uses magnetic fields to stimulate nerve cells in the brain and has proven safe for both healthy individuals and those with conditions like major depression.

Common side effects are usually mild, such as headaches or lightheadedness, while serious side effects remain rare. As a non-invasive treatment, TMS does not involve surgery, reducing the risk of complications.

Overall, TMS is considered a safe option for targeting brain networks, with studies supporting its use across various groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for targeting brain networks because it represents a fresh approach to neurological treatment. Unlike typical medications that often affect the whole brain, TMS uses magnetic fields to precisely target specific brain areas, potentially reducing side effects and improving effectiveness. The intermittent theta burst stimulation protocol used in TMS can be tailored to each person's brain anatomy, offering a personalized treatment that current options lack. Moreover, TMS is non-invasive and might show results faster than traditional therapies, making it a promising alternative for patients seeking quicker relief.

What evidence suggests that transcranial magnetic stimulation is effective for brain network targeting?

Research has shown that transcranial magnetic stimulation (TMS), which participants in this trial may receive, can effectively target specific brain areas. Studies have found that TMS improves connections in brain regions involved in focus and decision-making. This trial will compare personalized TMS treatments to sham treatments. Previous studies have demonstrated significant improvements in thinking skills with personalized TMS compared to sham treatments. Evidence suggests that TMS can be adjusted to fit individual brain patterns, enhancing its effectiveness. Overall, TMS has a strong record of altering brain activity to boost mental function. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This clinical trial is for healthy volunteers interested in contributing to research on brain stimulation. Participants will undergo MRI scans and TMS sessions while completing tasks, with the aim of improving response times and accuracy.

Inclusion Criteria

No metal implants

Absent of lesions or tumors from MRI scans

I understand the study and can agree to participate.

Exclusion Criteria

I cannot stay still when required.

The presence of a cardiac pacemaker or pacemaker wires

Prosthetic heart valves

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Data Collection

Participants undergo MRI scanning to collect brain data for analysis

1 visit

1 visit (in-person)

TMS Treatment

Participants receive TMS stimulations and perform computer-based tasks

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for response time and response error in tasks

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study tests a new method for targeting brain networks using Transcranial Magnetic Stimulation (TMS) guided by MRI data. It involves two visits: one for MRI scanning and another for four TMS sessions with EEG monitoring during task performance.

How Is the Trial Designed?

Group I: Transcranial Magnetic Stimulation Experimental Treatment 1 Intervention

TMS with the intermittent theta burst stimulation protocol will be applied to the computed brain targets based on the MRI data of each participants.

Group II: Sham Transcranial Magnetic Stimulation Placebo Group 1 Intervention

Sham TMS coils will be applied to stimulate the brain targets. No magnetic field will be generated using the sham coil. It will play sounds similar to the true TMS stimulations with the pulsed weak electric current applied to the scalp to generate a similar feeling as in true stimulations.

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has not been thoroughly studied for side effects, with the main known risk being the acute production of seizures.

While tissue damage from rTMS is unlikely, there are concerns about potential cognitive effects and the possibility of long-term changes in brain function that have not yet been fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. Wassermann, EM.[2005]

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]

Mild adverse effects (MAEs) from transcranial magnetic stimulation (TMS) occur in about 5% of sessions, with most symptoms like headache and nausea reported after the sessions, particularly during initial treatments.

The study found no significant links between participant characteristics (age and gender) or TMS parameters (frequency and intensity) and the occurrence of MAEs, suggesting that initial participant anxiety may play a role in these reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. Maizey, L., Allen, CP., Dervinis, M., et al.[2022]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) is a promising non-invasive brain stimulation technique that can enhance brain excitability and potentially improve conditions like stroke, Parkinson's disease, and depression, as discussed in a 2010 symposium with insights from both animal studies and small clinical trials.

While there is significant interest and some signs of therapeutic success with rTMS, the current models explaining its effects may need refinement to fully understand the underlying mechanisms and outcomes observed in various studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain stimulation and brain repair--rTMS: from animal experiment to clinical trials--what do we know? Platz, T., Rothwell, JC.[2013]

Repetitive magnetic stimulation (rTMS) is a non-invasive and painless technique that can effectively activate specific areas of the brain, making it useful for studying language, memory, and visual perception.

rTMS shows potential therapeutic benefits for conditions like movement disorders and depression, but there are safety considerations regarding its potential to induce seizures, which are addressed in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. Brandt, SA., Ploner, CJ., Meyer, BU.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894951/

Repetitive transcranial magnetic stimulation regulates ... This study aims to explore the potential of targeted rTMS to regulate effective connectivity within the default mode network (DMN) and the executive control ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S105381192200581X

Personalizing repetitive transcranial magnetic stimulation ... The study aims to develop a personalized repetitive transcranial magnetic stimulation (rTMS) protocol and evaluate its feasibility in optimizing the treatment ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818365

Effectiveness of Personalized Hippocampal ... Personalized hippocampal network–targeted stimulation demonstrated a significant improvement in cognition and functional performances compared with the sham ...

4. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(20)31668-1/fulltext

Using Brain Imaging to Improve Spatial Targeting of ... Transcranial magnetic stimulation (TMS) is an effective treatment for depression but is limited in that the optimal therapeutic target ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10311181/

Effects of repetitive transcranial magnetic stimulation and their ... In this review, we collected data on the brain modulation of participants who received rTMS and analyzed them using brain connectivity network techniques based ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of major depression.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21000887

Targeting repetitive transcranial magnetic stimulation in ... First, it is important to specifically delineate the cortical target for stimulation: whether this is a specific brain region, a hub in a specific network or an ...

9. nature.com nature.com/articles/s41386-025-02225-w

Neurodevelopmental considerations for transcranial ... A promising tool for non-invasive, circuit-based intervention in youth is repetitive transcranial magnetic stimulation (rTMS). Research in ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ... This randomized clinical trial compares the effectiveness between repetitive transcranial magnetic stimulation and lithium in preventing ...