TMS for Depression

(SCC-TMS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Antidepressants

Must not be taking: Seizure-inducing medications

Disqualifiers: Psychosis, Epilepsy, Dementia, others

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

Compensation: Varies

Number of Visits: 34

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to Transcranial Magnetic Stimulation (TMS), a non-invasive treatment using magnetic fields to stimulate brain nerve cells. The goal is to determine if different TMS frequencies can safely and effectively aid individuals with severe Major Depressive Disorder (MDD) who haven't found relief with other treatments. Participants must have tried at least two different antidepressant medications and therapies without success. The study involves regular mood assessments and up to 30 TMS sessions over six weeks. It offers those with difficult-to-treat depression a chance to explore a new treatment option. As an unphased trial, this study allows participants to contribute to innovative research and potentially benefit from a novel treatment approach.

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 must have failed to respond to at least two different classes of antidepressant medications and augmentation therapies, which suggests that continuing current medications might be allowed.

What prior data suggests that Transcranial Magnetic Stimulation is safe for treating depression?

Research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe and well-tolerated. In one study, only 12.4% of older adults experienced any side effects, with serious problems being even rarer. Another study confirmed TMS's safety for teenagers and young adults with depression. An expert panel reviewed nearly 2,400 studies and agreed that TMS is safe, even for those who haven't improved with other treatments. The FDA has approved TMS for depression, migraines, and OCD, indicating its safety for these conditions. Overall, evidence supports TMS as a safe treatment option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive approach to treating depression by using magnetic fields to stimulate nerve cells in the brain. Unlike traditional treatments like antidepressant medications or psychotherapy, TMS directly targets specific areas of the brain associated with mood regulation without the systemic side effects often seen with medications. Researchers are excited about TMS because it provides an option for those who haven't found relief with standard treatments and has the potential for quicker results with fewer side effects.

What evidence suggests that TMS might be an effective treatment for depression?

Research has shown that Transcranial Magnetic Stimulation (TMS) can effectively treat major depressive disorder. Studies have found that TMS significantly improves depression symptoms, with 30% to 60% of patients experiencing improvement and up to 37% achieving complete relief. One large study reported a 47% reduction in depression scores after just a few days of treatment. Overall, TMS offers a promising option for people with depression, especially those who haven't found relief with other treatments. Participants in this trial will receive SCC-Determined TMS, an experimental approach to TMS, to further evaluate its effectiveness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with severe Major Depressive Disorder who haven't improved after trying at least two different antidepressants and psychotherapy. Participants must be able to commit to the study schedule and visits, but can't join if they have a high seizure risk, certain neurological conditions, scalp infections, mental incapacity, or magnetic-sensitive implants near the treatment area.

Inclusion Criteria

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

Subjects are willing and able to adhere to the treatment schedule and required study visits

I have tried at least 2 antidepressants without improvement.

Exclusion Criteria

I have been diagnosed with a psychotic disorder during my current depressive episode.

I am at a higher risk of having seizures due to my family history, past stroke, or my current medications.

I have a metal implant or device near my head that might be affected by magnets.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Frequency Determination

Subjects undergo QEEG and motor threshold determination to establish individual TMS frequency

1 week

1 visit (in-person)

Treatment

Participants receive up to 30 TMS treatments at individualized frequencies, with weekly mood/symptom assessments

6 weeks

Up to 30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial magnetic Stimulation

Trial Overview

The study tests repetitive Transcranial Magnetic Stimulation (TMS) at non-standard frequencies to treat depression. It involves an initial assessment using EEG, determining TMS settings tailored for each person, weekly mood checks, and up to 30 TMS sessions over a maximum of six weeks.

How Is the Trial Designed?

Group I: SCC-Determined TMS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a study of 30 patients with major depressive episodes, 73% achieved remission after a second course of Transcranial Magnetic Stimulation (TMS), indicating its effectiveness even after initial treatment failure.

Among patients who did not respond to the first TMS course, 75% achieved remission with the second course, suggesting that TMS can be a valuable option for those who relapse or do not initially respond.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Courses of Transcranial Magnetic Stimulation (TMS) in Major Depressive Episodes for Initial Responders and Non-Responders. Pridmore, S., Erger, S., May, T.[2022]

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]

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]

Transcranial magnetic stimulation (TMS) is a safe and effective treatment for depression, showing therapeutic effects comparable to psychotherapy and antidepressants.

Further research is needed to enhance the efficiency of TMS and to understand its mechanisms of action, as well as to determine the duration of its antidepressant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial magnetic stimulation as a treatment for depression]. Schutter, DJ.[2011]

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) is an effective and safe treatment for major depressive disorder (MDD), showing significant improvements in quality of life (QOL) and functional status in 307 outpatients after an acute treatment course.

Patients reported statistically significant enhancements in mental and physical health across various domains, indicating that TMS not only alleviates depressive symptoms but also leads to meaningful improvements in overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. Janicak, PG., Dunner, DL., Aaronson, ST., et al.[2022]

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]

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Clinician-assessed response rate (CGI-S) was 58.0% and remission rate was 37.1%. Patient-reported response rate ranged from 56.4 to 41.5% and remission rate ...

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