rTMS for Brain Response

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Bupropion, Olanzapine, Chlorpromazine, Lithium

Disqualifiers: Neurological disease, Seizures, Psychotic, Bipolar, Substance abuse, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses magnetic fields to stimulate the brain and studies its effects on brain function and visual attention in participants.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that substantially reduce the seizure threshold, such as bupropion, olanzapine, chlorpromazine, or lithium. If you are on these medications, you may need to stop taking them to participate.

What data supports the effectiveness of this treatment?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is effective in treating major depressive disorder and can help with motor recovery after a stroke. It works by changing brain activity, which can improve symptoms. ^{1 2 3 4 5}

Is repetitive transcranial magnetic stimulation (rTMS) generally safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety since the 1990s, with guidelines updated in 2021. While generally considered safe, it can cause side effects like temporary hearing changes and, rarely, seizures. Safety guidelines help minimize risks, and it's important to follow them closely. ^{6 7 8 9 10}

How does the treatment rTMS differ from other treatments for this condition?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive and painless method that uses magnetic fields to stimulate specific areas of the brain, unlike other treatments that may involve medication or surgery. It can effectively target and modulate brain activity, which is particularly useful for conditions like depression and movement disorders, without the need for direct physical intervention. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for men and women aged 18 to 65 who understand English well, are either left- or right-handed, and have no history of neurological disorders or seizure risks. It's not suitable for those with MRI contraindications like metal implants, unstable medical conditions, head trauma history, active substance abuse, psychotic or bipolar disorders, pregnancy/breastfeeding status, or on certain medications.

Inclusion Criteria

I am between 18 and 65 years old.

Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales

Left- or Right-handed

Exclusion Criteria

I have been diagnosed with a psychotic or bipolar disorder.

Those with a contraindication for MRIs (e.g. implanted metal)

Any unstable medical condition

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo rTMS to the visual cortex and perform visual task paradigms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ssVEP response amplitude and visual contrast perceptual sensitivity

60 minutes

Treatment Details

Interventions

• repetitive transcranial magnetic stimulation

Trial Overview The study tests how rTMS (a non-invasive brain stimulation technique) affects the brain's plasticity using EEG to measure responses while participants do visual tasks. The effect of attention on these changes is also studied by having participants focus on different parts of a visual field during the task.

Participant Groups

Group I: Visual Cortex, 10 Hz rTMS, Unattended Experimental Treatment 1 Intervention

Group II: Visual Cortex, 10 Hz rTMS, Attended Experimental Treatment 1 Intervention

Group III: Visual Cortex, 1 Hz rTMS, Unattended Experimental Treatment 1 Intervention

Group IV: Visual Cortex, 1 Hz rTMS, Attended Experimental Treatment 1 Intervention

Group V: Visual Cortex, Sham, Unattended Placebo Group 1 Intervention

Group VI: Visual Cortex, Sham, Attended Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

In a preliminary study involving four patients with relapsed major depressive disorder, rapid transcranial magnetic stimulation (rTMS) showed significant improvement in depression ratings after treatment.

The results indicated that rTMS can be effectively used again in patients who had previously responded well to this therapy, suggesting its potential for repeated use in managing relapsed depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation is effective in the treatment of relapse of depression. Dannon, PN., Schreiber, S., Dolberg, OT., et al.[2022]

In a chronic stroke patient, 5 days of low-frequency rTMS on the intact motor cortex led to improvements in motor function and neuropsychological symptoms without any adverse effects.

Neuroimaging revealed that these improvements were linked to changes in brain activity, specifically a reduction in hyperactivity and reorganization in the opposite hemisphere, suggesting a mechanism of neuroplasticity that supports recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and neuroplastic effects of low-frequency rTMS of the unaffected hemisphere in a chronic stroke patient: a concomitant TMS and fMRI study. Salatino, A., Berra, E., Troni, W., et al.[2014]

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]

In a study involving 9 normal volunteers, rapid-rate transcranial magnetic stimulation (rTMS) was found to be generally safe, but it caused temporary hearing threshold shifts in 3 subjects and a seizure in one subject at the highest intensity, indicating a potential risk for seizures.

The study also demonstrated that rTMS can increase cortical excitability in contralateral muscles, with the extent of this effect varying based on the intensity and frequency of the stimulation, suggesting a need for careful monitoring and guidelines to mitigate side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of rapid-rate transcranial magnetic stimulation in normal volunteers. Pascual-Leone, A., Houser, CM., Reese, K., et al.[2019]

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) was found to be safe for a patient with an implanted subdural cortical electrode, showing no serious adverse effects during treatment.

Ex-vivo experiments indicated that rTMS caused only a slight increase in coil temperature and no displacement of the electrodes, suggesting that rTMS can be safely applied in clinical settings for patients with such implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Phielipp, NM., Saha, U., Sankar, T., et al.[2019]

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]

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]

Suprathreshold rTMS over the left primary sensorimotor cortex significantly increased brain activity in the stimulated area and supplementary motor area (SMA) in most subjects, indicating effective neuronal activation.

Subthreshold rTMS did not activate the primary sensorimotor cortex but still modulated activity in remote areas like the SMA and lateral premotor cortex, suggesting it influences corticocortical connections without inducing motor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthreshold high-frequency TMS of human primary motor cortex modulates interconnected frontal motor areas as detected by interleaved fMRI-TMS. Bestmann, S., Baudewig, J., Siebner, HR., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Initial Response to Transcranial Magnetic Stimulation Treatment for Depression Predicts Subsequent Response. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of subthreshold 1 Hz repetitive TMS on cortico-cortical and interhemispheric coherence. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: An analysis from the randomised non-inferiority THREE-D trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation is effective in the treatment of relapse of depression. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Behavioral and neuroplastic effects of low-frequency rTMS of the unaffected hemisphere in a chronic stroke patient: a concomitant TMS and fMRI study. [2014]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Safety of rapid-rate transcranial magnetic stimulation in normal volunteers. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. [2005]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. [2019]

10. Ireland 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. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Subthreshold high-frequency TMS of human primary motor cortex modulates interconnected frontal motor areas as detected by interleaved fMRI-TMS. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in motor cortical excitability induced by high-frequency repetitive transcranial magnetic stimulation of different stimulation durations. [2008]

14. England pubmed.ncbi.nlm.nih.gov

Functional MRI of cortical activations induced by transcranial magnetic stimulation (TMS). [2019]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Interhemispheric effects of high and low frequency rTMS in healthy humans. [2022]