Transcranial Magnetic Stimulation for Depression

Overseen By Courtney Caves

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Investigational drugs

Disqualifiers: Psychotic, Bipolar, Anorexia, Bulimia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of brain stimulation called theta burst stimulation (TBS) to determine if it can reduce suicidal thoughts in teenagers with Major Depressive Disorder (MDD). Over 10 days, participants will receive either the real TBS treatment using the MagVenture TMS Therapy System with Theta Burst Stimulation or a sham (fake) treatment for comparison. The goal is to assess whether this approach can improve mental health outcomes over the following year. Teens aged 12-18 who have experienced depression for at least four weeks and have significant symptoms may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could significantly enhance mental health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that taking an antidepressant is not required for participation, and medication status will be recorded.

What prior data suggests that this transcranial magnetic stimulation technique is safe for adolescents with Major Depressive Disorder?

Research shows that theta burst stimulation (TBS), a type of transcranial magnetic stimulation (TMS), is generally well-tolerated. Studies have found that the FDA has approved TMS, including TBS, for treating depression, indicating its safety. In everyday use, TBS has been frequently used for depression in countries like Sweden, with results similar to those in clinical trials. While some people may not respond to the treatment, serious side effects are rare. Most people experience only minor side effects, such as headaches or scalp discomfort, which usually resolve quickly. Overall, TBS appears to be a safe option for managing depression symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial magnetic stimulation (TMS) with theta burst stimulation for depression because it offers a non-invasive, fast-acting alternative to traditional treatments like antidepressant medications and electroconvulsive therapy. Unlike these standard options, which can take weeks to show results, TMS with theta burst stimulation has the potential to produce improvements in just a few days. This method uses magnetic fields to stimulate nerve cells in the brain, specifically targeting areas involved in mood regulation without the systemic side effects associated with medication. By enhancing brain activity in targeted regions, it provides a promising new avenue for individuals who have not responded well to other treatments.

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

Research shows that theta burst stimulation (TBS), a type of transcranial magnetic stimulation (TMS), can help reduce depression symptoms. In this trial, participants will receive either active sequential bilateral accelerated TBS or a sham version of the treatment. Studies have found that accelerated TBS, which uses quick bursts of magnetic pulses, can be effective for people who haven't responded to other treatments. TBS has improved mood in patients with depression, and some trials suggest it can help with treatment-resistant depression. While evidence of its potential is increasing, more research is needed to confirm its effectiveness for suicidal thoughts in teenagers with depression. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul Croarkin, DO, MS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adolescents aged 12-18 with Major Depressive Disorder and suicidal thoughts can join this trial. They must have a depressive episode lasting at least 4 weeks but under 3 years, and not show significant improvement before the trial starts. Participants need consent from a guardian, may be on antidepressants, and females must use birth control.

Inclusion Criteria

I have been diagnosed with major depression according to DSM-5.

I am either female or male.

I am experiencing severe depression and have thoughts of harming myself.

Exclusion Criteria

Any true positive findings on the TMS safety screening form

Implanted medication pumps and cardiac pacemakers

Pregnancy or suspected pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sequential bilateral accelerated theta burst stimulation (aTBS) or sham TBS, with three sessions administered daily for 10 days

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of suicidal ideation and hospitalizations

12 months

What Are the Treatments Tested in This Trial?

Interventions

• MagVenture TMS Therapy System w/Theta Burst Stimulation
• Sham MagVenture TMS Therapy System w/Theta Burst Stimulation

Trial Overview The study tests if theta burst stimulation (TBS), a new type of transcranial magnetic stimulation (TMS), helps reduce suicidal ideation in adolescents with depression over 10 days, monitoring outcomes for a year. It compares real TBS to sham (fake) treatment to see if there's an improvement.

How Is the Trial Designed?

Group I: Sequential bilateral accelerated theta burst stimulation Active Control 1 Intervention

Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Group II: Sham seqential billateral accelerated theta burst stimulation Placebo Group 1 Intervention

Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

MagVenture TMS Therapy System w/Theta Burst Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as MagVenture TMS Therapy System w/Theta Burst Stimulation for:

• Major Depressive Disorder (MDD) with suicidal ideation

Approved in European Union as MagVenture TMS Therapy System w/Theta Burst Stimulation for:

• Major Depressive Disorder (MDD) with suicidal ideation

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), has been shown to be effective in treating major depression, with a response rate effect size of 0.38 and a remission rate effect size of 0.20 based on a meta-analysis of 10 studies involving 591 participants.

TBS is not only effective but also has a favorable safety profile, showing no major adverse events, and is more efficient in terms of time and energy compared to standard rTMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of theta-burst stimulation for major depression: A systematic review and meta-analysis. Chu, HT., Cheng, CM., Liang, CS., et al.[2021]

Continuous theta burst stimulation (cTBS) was found to be safe and well-tolerated in patients with major depressive disorder (MDD) or bipolar depression (BD), with no significant differences in adverse events compared to sham treatment.

However, the meta-analysis of three randomized controlled trials involving 78 participants showed no significant improvement in depression scores or response rates with cTBS compared to sham, indicating that cTBS may not provide a therapeutic advantage for treating major depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. Cai, DB., Qin, XD., Qin, ZJ., et al.[2023]

In a study of 54 patients with major depression, the combination of intermittent theta burst stimulation (iTBS) and low-frequency rTMS (LF-rTMS) significantly improved depression and anxiety symptoms more than high-frequency rTMS (HF-rTMS).

The results suggest that iTBS combined with LF-rTMS may be a promising alternative therapy for major depression, offering both efficacy and time-saving benefits compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left intermittent theta burst stimulation combined with right low-frequency rTMS as an additional treatment for major depression: A retrospective study. Mi, Y., Ji, Y., Lou, Z., et al.[2022]

In a study of 27 participants, a prolonged intermittent theta burst stimulation (piTBS) protocol using 1,800 pulses showed limited effectiveness for major depressive disorder, with only 18.2% of participants achieving a response and 9.1% reaching remission.

Safety and tolerability were concerns, as 18.5% of participants experienced issues, suggesting that while piTBS is a promising approach, further research is needed to optimize its parameters and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. Richard, M., Noiseux, C., Desbeaumes Jodoin, V., et al.[2022]

In a study involving 300 patients with treatment-resistant depression, accelerated bilateral theta burst stimulation (TBS) was found to be effective and safe, with a treatment response rate of 43.7% and a remission rate of 28.2%.

The study revealed no significant differences in efficacy between different TBS intensities or when compared to traditional unilateral 10 Hz rTMS, indicating that the accelerated TBS does not provide faster antidepressant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial. Chen, L., Thomas, EHX., Kaewpijit, P., et al.[2022]

In a randomized-controlled trial involving 32 patients with major depression, bilateral theta burst stimulation (TBS) to the dorsolateral prefrontal cortex showed a significant increase in treatment response compared to sham stimulation, with 9 responders in the TBS group versus 4 in the sham group.

The study also indicated a trend towards higher remission rates in the TBS group as measured by the Beck Depression Inventory, suggesting that TBS may enhance the effectiveness of ongoing medication and psychotherapy in treating major depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. Plewnia, C., Pasqualetti, P., Große, S., et al.[2018]

Citations

1. magventure.com magventure.com/

MagVenture TMS Machines MagVenture is a TMS machines market-leading manufacturer. TMS gives new hope to patients suffering from depression, OCD and chronic pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04701840

Sequential Bilateral Accelerated Theta Burst Stimulation in ... The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X2100156X

Accelerated theta burst stimulation for the treatment of ... Treatment resistance rates of up to 30 % have been reported [2], resulting in distress and disability for those living with depression, along with carer burden ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05939115

Intensive Accelerated Theta Burst Stimulation in Treatment ... This study aims to reduce morbidity and mortality of bipolar depressive patients and to improve overall functioning. Objectives: To compare efficacy of left ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11238064/

Accelerated Intermittent Theta-Burst Stimulation and ... This randomized clinical trial assesses the effectiveness of accelerated intermittent theta-burst stimulation for depressive symptom reduction

6. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723002604

Outcome of transcranial magnetic intermittent theta-burst ... iTBS is the most utilized rTMS protocol for depression in Sweden. Real-life response rates of iTBS are similar to clinical trials.

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.pn.2018.pp8a6

FDA Clears 3-Minute TMS Protocol for Depression The FDA has cleared a three-minute treatment protocol for a repetitive transcranial magnetic stimulation (rTMS) system by Magventure, the company announced ...