Frequency-Varied TMS for Depression

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will analyze the feasibility, safety, and tolerability of administering repetitive Transcranial magnetic stimulation(TMS) at frequencies other than standard 10 Hz. This study will enroll 50 subjects who will undergo one quantitative electroencephalograph, one TMS procedure to determine the appropriate frequency and intensity for treatment, weekly mood/symptom assessments, and up to 30 TMS treatments. Subjects will be asked to participate for up to 6 weeks.

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, if you are on medications that increase the risk of seizures, you may not be eligible to participate.

What data supports the effectiveness of the treatment Spectral Correlation Coefficient-based TMS for depression?

Research shows that synchronizing TMS (transcranial magnetic stimulation) with brain activity can make it more effective for treating depression. Studies also indicate that TMS is generally effective for depression, especially when new stimulation methods are used. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS) is generally considered safe for treating depression, with studies showing it is well-tolerated by patients. It has been approved by the US Food and Drug Administration for major depressive disorder, and safety reviews provide guidelines for its clinical use. ^{6 7 8 9 10}

How is the Frequency-Varied TMS treatment for depression different from other treatments?

Frequency-Varied TMS (transcranial magnetic stimulation) for depression is unique because it uses varying frequencies to target brain oscillations, which are electrical patterns in the brain, to potentially improve mood. This approach is different from standard TMS treatments that typically use a fixed frequency, aiming to better modulate brain activity and improve treatment outcomes. ^{3 4 11 12 13}

Eligibility Criteria

This trial is for adults aged 18-65 with severe Major Depressive Disorder who haven't improved after at least four different antidepressant medications and two augmentation therapies. Participants must have tried effective psychotherapy and be able to commit to the study schedule.

Inclusion Criteria

I am receiving two or more approved additional treatments (not including Benzodiazepines).

I have been diagnosed with severe Major Depressive Disorder.

My condition did not improve after trying two different types of treatment.

Exclusion Criteria

I have an infection or poor skin condition on my scalp.

I am unable to understand or sign the consent form due to mental or legal reasons.

I have a neurological condition like epilepsy or severe head trauma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo one quantitative electroencephalograph and one TMS procedure to determine the appropriate frequency and intensity for treatment

1 week

1 visit (in-person)

Treatment

Participants receive up to 30 TMS treatments at individualized frequencies based on SCC-determined patterns

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Spectral Correlation Coefficient-based TMS

Trial Overview The trial tests repetitive Transcranial Magnetic Stimulation (TMS) at non-standard frequencies for treating depression. It involves an initial assessment, determining treatment frequency/intensity, weekly mood checks, and up to 30 TMS sessions over six weeks.

Participant Groups

Group I: SCC Experimental Treatment 1 Intervention

Subjects will be treated according to their frequency response pattern which may show one or more distinct frequencies of stimulation that generated increased SCC

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

Recent studies on repetitive transcranial magnetic stimulation (rTMS) for depression have demonstrated significantly improved clinical outcomes, with a pooled effect size of -0.76 from 5 studies involving 274 patients, compared to -0.35 from earlier studies.

The findings indicate that new parameters of rTMS stimulation may enhance its antidepressant effects, suggesting a potential advancement in treatment strategies for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. Gross, M., Nakamura, L., Pascual-Leone, A., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) is generally a well-tolerated treatment for depression, with mild side effects like headaches being the most common, while severe adverse effects are rare.

Special precautions are necessary for certain groups, such as adolescents, pregnant women, and individuals with metal implants, but with proper assessment and monitoring, rTMS can be safely administered to many patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. Taylor, R., Galvez, V., Loo, C.[2019]

Transcranial magnetic stimulation (TMS) is shown to be safe for patients with major depressive disorder, with no significant increase in dropout rates or serious adverse events compared to sham treatment, based on a meta-analysis of 53 trials involving 3,273 participants.

While TMS may lead to some mild and transient non-serious adverse events like headaches and discomfort, these side effects are manageable, suggesting that TMS can be a viable treatment option either alone or alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. Wang, WL., Wang, SY., Hung, HY., et al.[2022]

In a study of 301 medication-free patients with treatment-resistant major depression, transcranial magnetic stimulation (TMS) significantly improved quality of life (QOL) and functional status compared to sham treatment during a 6-week trial.

The benefits of TMS were not only observed during the acute treatment phase but also sustained over a 24-week follow-up, indicating that TMS provides durable improvements in patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. Solvason, HB., Husain, M., Fitzgerald, PB., et al.[2018]

Transcranial magnetic stimulation (TMS) was effective in treating treatment-resistant depression, with a response rate of 50.6% and a remission rate of 24.7% after 6 weeks of treatment in a cohort of 100 patients.

TMS was well tolerated, showing a low discontinuation rate of 3% and no serious adverse events, indicating its safety as an adjunctive treatment for patients who have not responded to other antidepressant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. Connolly, KR., Helmer, A., Cristancho, MA., et al.[2022]

References

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

Brain oscillation-synchronized stimulation of the left dorsolateral prefrontal cortex in depression using real-time EEG-triggered TMS. [2020]

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

Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. [2018]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[EEG spectral characteristics in resistant depression patients on transcranial magnetic stimulation treatment]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Characterizing Cortical Oscillatory Responses in Major Depressive Disorder Before and After Convulsive Therapy: A TMS-EEG Study. [2021]

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

Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]

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

Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. [2022]

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

Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. [2022]

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

Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. [2018]

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

Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. [2022]

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

Left dorso-lateral repetitive transcranial magnetic stimulation affects cortical excitability and functional connectivity, but does not impair cognition in major depression. [2022]

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

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

13. England pubmed.ncbi.nlm.nih.gov

Abnormal brain oscillations persist after recovery from bipolar depression. [2020]