TMS for Depression

Overseen By Nikita Vincecruz, BS

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: Psychotic disorders, Neurological conditions, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on medications that increase the risk of seizures, you may need to stop those.

What data supports the effectiveness of the treatment Open-label TMS for depression?

Research shows that transcranial magnetic stimulation (TMS) can effectively reduce symptoms of major depression, especially in patients who have not responded to other treatments. Studies indicate that daily TMS sessions over several weeks can improve mood and quality of life in people with depression. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS) is generally considered safe for treating major depression, with studies showing it is well-tolerated by patients. ^{3 5 6 7 8}

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

Transcranial magnetic stimulation (TMS) is unique because it is a noninvasive treatment that uses magnetic fields to stimulate nerve cells in the brain, specifically targeting the left prefrontal cortex, which is associated with mood regulation. Unlike medications, TMS does not involve systemic side effects or drug interactions, making it a novel option for those who have not responded to traditional antidepressant drugs. ^{1 2 3 7 9}

Eligibility Criteria

This trial is for adults aged 18-65 with moderate to severe Major Depressive Disorder, who haven't improved after trying at least two different types of antidepressants and psychotherapy. Participants must be able to commit to an accelerated treatment schedule but can't join if they have certain neurological conditions, risk of seizures, psychotic disorders, or magnetic-sensitive implants in their body.

Inclusion Criteria

I have undergone psychotherapy for my depression.

I am between 18 and 65 years old.

Subjects are willing and able to adhere to the accelerated treatment schedule

Exclusion Criteria

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

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

I am able to understand and consent to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive 25 sessions of individualized a-rTMS over five days to treat Major Depressive Disorder

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Open-label TMS

Trial Overview The study tests the safety and effectiveness of a non-standard frequency accelerated repetitive Transcranial Magnetic Stimulation (a-rTMS) on patients hospitalized with depression. It involves brain activity recordings, one MRI scan, determining individual TMS settings, daily symptom checks, and receiving 25 TMS treatments over up to two weeks.

Participant Groups

Group I: Open-label 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+

Findings from Research

In an open-label extension study of trans-cranial magnetic stimulation (TMS) involving patients with medication-resistant major depressive disorder, those who previously received sham treatment showed a significant mean reduction in depression scores (MADRS) of -17.0 after 6 weeks of active TMS, with 42.4% achieving a response and 20.0% reaching remission.

Patients who had not responded to initial active TMS also benefited from continued treatment, showing a mean reduction of -12.5 in MADRS scores, with 26.0% responding and 11.0% remitting, indicating that longer courses of TMS may enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. Avery, DH., Isenberg, KE., Sampson, SM., et al.[2019]

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 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]

References

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

Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. [2019]

2. 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]

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

Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. [2019]

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

Repetitive transcranial magnetic stimulation of the prefrontal cortex in depression. [2022]

5. 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]

6. 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]

7. 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]

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

Dosing transcranial magnetic stimulation in major depressive disorder: Relations between number of treatment sessions and effectiveness in a large patient registry. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for the treatment of depression. [2010]