10 Participants Needed

TMS for Depression

(SCC-TMS Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Transcranial Magnetic Stimulation (TMS) for depression?

Research shows that Transcranial Magnetic Stimulation (TMS) is an effective treatment for major depression, with studies documenting improvements in patient-rated and clinician-rated outcomes. TMS has also been shown to improve quality of life in patients with depression who do not respond to medication.12345

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS) is generally considered safe for treating depression, with multiple studies and reviews supporting its safety in humans.46789

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

Transcranial Magnetic Stimulation (TMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which can help improve symptoms of depression. Unlike medications, TMS does not involve taking drugs and is often used when other treatments, like antidepressants, have not been effective.37101112

What is the purpose of this trial?

This study will investigate the feasibility, safety, and tolerability of administering repetitive Transcranial magnetic stimulation(TMS) at frequencies other than standard 10 Hz. This study will enroll 10 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.

Eligibility Criteria

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.
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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.
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Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: SCC-Determined TMSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Findings from Research

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

Transcranial magnetic stimulation in the management of mood disorders. [2022]
Clinical outcomes in a large registry of patients with major depressive disorder treated with Transcranial Magnetic Stimulation. [2021]
[Transcranial Magnetic Stimulation in depression: results of bi-weekly treatment]. [2019]
Improvement in quality of life with left prefrontal transcranial magnetic stimulation in patients with pharmacoresistant major depression: acute and six month outcomes. [2018]
Dosing transcranial magnetic stimulation in major depressive disorder: Relations between number of treatment sessions and effectiveness in a large patient registry. [2023]
Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]
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]
Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. [2022]
Safety of transcranial magnetic stimulation in unipolar depression: A systematic review and meta-analysis of randomized-controlled trials. [2022]
Transcranial magnetic stimulation for patients with depression. [2008]
[Transcranial magnetic stimulation as a treatment for depression]. [2011]
Second Courses of Transcranial Magnetic Stimulation (TMS) in Major Depressive Episodes for Initial Responders and Non-Responders. [2022]
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