Transcranial Magnetic Stimulation for Brain Activity Study

Recruiting at 1 trial location

Overseen By Derek Nee, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Psychiatric, Neurological, Pro-epileptic

Disqualifiers: Psychiatric, Neurological, Epilepsy, Tinnitus, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 sessions

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking medications for psychiatric or neurological disorders, or any drugs that are pro-epileptic, you will not be eligible to participate in this trial.

What data supports the effectiveness of the treatment transcranial magnetic stimulation?

Research shows that transcranial magnetic stimulation (TMS) is effective in treating major depressive disorder (MDD), especially for patients who do not respond to antidepressant medications. Studies have documented positive outcomes in both short-term and long-term use of TMS for depression. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS) is generally considered safe, but it can cause mild side effects like headaches and nausea, and in rare cases, seizures. Pain at the stimulation site is also common, especially in children and adolescents. Guidelines exist to ensure its safe use, particularly for repetitive TMS (rTMS), which is more powerful and potentially riskier. ^{6 7 8 9 10}

How is transcranial magnetic stimulation different from other treatments for brain activity?

Transcranial magnetic stimulation (TMS) is unique because it is a non-invasive and painless method that uses electromagnetic pulses to stimulate specific areas of the brain. Unlike other treatments, TMS can directly assess and influence brain connectivity and reactivity, making it a valuable tool for studying brain functions and potentially treating various neurological conditions. ^{1 11 12 13 14}

What is the purpose of this trial?

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.

Research Team

Derek Nee, PhD

Principal Investigator

Florida State University

Eligibility Criteria

This trial is for individuals who are eligible to undergo transcranial magnetic stimulation (TMS), a non-invasive procedure. Specific eligibility criteria details are not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Right-handed

I have been fluent in English since I was 6 years old.

Exclusion Criteria

I am not taking any medications that can cause seizures.

History of psychiatric disorders

I am taking medication for a mental health or neurological condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial fMRI session to localize TMS targets using the Comprehensive Control Task (CCT)

1 session

1 visit (in-person)

Treatment

Participants undergo 3 counter-balanced sessions of TMS targeting different brain sites, followed by fMRI

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for changes in PFC-PPC activation and behavioral performance

Immediately after intervention

Treatment Details

Interventions

• transcranial magnetic stimulation

Trial Overview The study aims to investigate the effects of TMS on two areas of the brain: the prefrontal cortex and posterior parietal cortex. The exact nature of what's being tested, such as frequency or duration of TMS, isn't specified here.

Participant Groups

Group I: MFG-TMS Experimental Treatment 1 Intervention

Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.

Group II: IPL-TMS Experimental Treatment 1 Intervention

Transcranial magnetic stimulation to the inferior parietal lobule. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.

Group III: S1-TMS Active Control 1 Intervention

Transcranial magnetic stimulation to the primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

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]

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]

Transcranial magnetic stimulation (TMS) has a very low seizure risk, with only 0.08 seizures reported per 1,000 sessions, and less than 0.02 seizures per 1,000 sessions when guidelines are followed for individuals without known risk factors.

The study found that exceeding safety guidelines increases the risk of seizures, and seizures are more likely to occur during the first few TMS sessions, suggesting that TMS is generally safe when administered properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Lerner, AJ., Wassermann, EM., Tamir, DI.[2021]

In a study involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

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]

Transcranial magnetic stimulation (TMS) is a non-invasive and painless method used since 1985 to stimulate the brain and cranial nerves, with applications in both diagnostics and treatment.

Repetitive TMS can modify the excitability of the cerebral cortex, making it a promising therapeutic tool for investigating neural circuitry and treating various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in clinical practice. Alisauskiene, M., Truffert, A., Vaiciene, N., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of corticospinal excitability after traumatic spinal cord injury using MEP recruitment curves: a preliminary TMS study. [2018]

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

Clinical outcomes in a large registry of patients with major depressive disorder treated with Transcranial Magnetic Stimulation. [2021]

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

Repetitive transcranial magnetic stimulation: Course and early prediction of response in depression. [2023]

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

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

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

A multisite, naturalistic, observational study of transcranial magnetic stimulation for patients with pharmacoresistant major depressive disorder: durability of benefit over a 1-year follow-up period. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. [2022]

9. 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]

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

Pain during transcranial magnetic stimulation in youth. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Neuronal responses to magnetic stimulation reveal cortical reactivity and connectivity. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation as a tool for cognitive studies. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in clinical practice. [2018]

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

Locating the motor cortex on the MRI with transcranial magnetic stimulation and PET. [2004]