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

Trial Summary

What is the purpose of this trial?

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 (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.

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 data supports the effectiveness of the treatment MagVenture TMS Therapy System with Theta Burst Stimulation for depression?

Research shows that theta burst stimulation (TBS), a type of repetitive transcranial magnetic stimulation (rTMS), can be effective for treating major depression. Studies indicate that TBS is a promising option due to its shorter treatment duration and lower intensity, which may improve the efficiency of rTMS for depression. ^{1 2 3 4 5}

How is the MagVenture TMS Therapy System with Theta Burst Stimulation different from other depression treatments?

The MagVenture TMS Therapy System with Theta Burst Stimulation (TBS) is unique because it uses a patterned form of magnetic stimulation that is shorter in duration and lower in intensity compared to traditional repetitive transcranial magnetic stimulation (rTMS), potentially improving efficiency and allowing for accelerated treatment schedules. ^{1 2 4 5 6}

Research Team

Paul Croarkin, DO, MS

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of theta-burst stimulation for major depression: A systematic review and meta-analysis. [2021]

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

Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. [2023]

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

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]

6. India 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. [2022]