Deep TMS for Depression

Recruiting at 8 trial locations

Overseen By Neelima Kunam, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brainsway

Must not be taking: Investigational drugs

Disqualifiers: Substance abuse, Psychotic disorders, Bipolar, 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: Unknown

Duration: 6 weeks

104 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device that uses magnetic pulses to stimulate the brain. It aims to help people with Major Depressive Disorder who have depressive episodes. The study will check if this new method is as safe and effective as current treatments. Magnetic seizure therapy (MST) is a potential alternative to electroconvulsive therapy (ECT) that may not adversely affect memory.

Will I have to stop taking my current medications?

The trial requires that participants are stable on their current medication for at least 2 months and do not change medications during the study period.

What data supports the effectiveness of the treatment Deep TMS for Depression?

Research shows that intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), is effective for treatment-resistant depression. It is as effective as the traditional rTMS but can be delivered in a much shorter time, making it a promising option for patients. ^{1 2 3 4 5}

Is Deep TMS safe for humans?

Research shows that Deep TMS, including forms like intermittent theta burst stimulation (iTBS), is generally safe for humans. Studies have reported no serious adverse events, although some participants experienced mild tolerability issues. ^{1 2 3 6 7}

How is Deep TMS with iTBS different from other depression treatments?

Deep TMS with iTBS is unique because it uses a newer form of magnetic stimulation that can be delivered in just 3 minutes, compared to the traditional 37.5-minute sessions, and it may help patients achieve remission faster by allowing multiple daily sessions. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder (MDD) who are experiencing a depressive episode. The specific details about eligibility criteria were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Satisfactory safety screening questionnaire for transcranial magnetic stimulation

I am able and willing to give my consent for treatment.

I have been diagnosed with major depression for at least 4 weeks.

Exclusion Criteria

Women who are breast-feeding

Investigators, site personnel directly affiliated with this study, and their immediate families

Any psychotic disorder (lifetime), including schizoaffective disorder or major depression with psychotic features or Bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the standard-of-care or investigational deep TMS protocol for Major Depressive Disorder

6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• Accelerated Intermittent Theta Burst Stimulation (iTBS) Deep Transcranial Magnetic Stimulation (Deep TMS)

Trial Overview The trial is testing an accelerated form of Theta Burst Stimulation using the Brainsway Deep TMS System. It aims to show that this new treatment method works as well as the current standard High Frequency stimulation protocol in treating MDD.

Participant Groups

Group I: Investigational stimulation group Experimental Treatment 1 Intervention

The experimental group will receive the new investigational deep TMS protocol

Group II: Standard-of-care stimulation group Active Control 1 Intervention

The control group will receive the currently FDA-cleared standard-of-care deep TMS protocol.

Accelerated Intermittent Theta Burst Stimulation (iTBS) Deep Transcranial Magnetic Stimulation (Deep TMS) is already approved in United States, European Union for the following indications:

Approved in United States as BrainsWay Deep TMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Smoking Cessation
• Anxious Depression

Approved in European Union as BrainsWay Deep TMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Smoking Cessation
• Alzheimer's Disease (AD)
• Autism
• Bipolar Disorder
• Chronic Pain
• Multiple Sclerosis (MS)
• Parkinson's Disease
• Post-Stroke Rehabilitation
• Post-Traumatic Stress Disorder (PTSD)
• Negative Symptoms of Schizophrenia

Who Is Running the Clinical Trial?

Brainsway

Lead Sponsor

Trials

38

Recruited

2,800+

Findings from Research

Intermittent theta-burst stimulation (iTBS) and high-frequency rTMS (HF-rTMS) show similar efficacy in treating treatment-resistant depression (TRD), with response rates of 48.0% for iTBS and 45.5% for HF-rTMS based on two high-quality randomized controlled trials involving 474 participants.

Both iTBS and HF-rTMS have comparable safety profiles, with similar rates of discontinuation and adverse events, such as headaches, indicating that iTBS is a safe alternative to HF-rTMS for patients with TRD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intermittent theta burst stimulation versus high-frequency repetitive transcranial magnetic stimulation for patients with treatment-resistant depression: a systematic review. Lan, XJ., Yang, XH., Qin, ZJ., et al.[2023]

In a study involving 208 participants with treatment-resistant depression, both twice-daily and once-daily intermittent theta burst stimulation (iTBS) protocols showed improvements in depression scores, but there was no significant difference in efficacy between the two schedules after 10 and 30 days.

Response and remission rates were low in both treatment groups, indicating that neither protocol significantly accelerated the improvement of depressive symptoms in patients with treatment-resistant depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study. Blumberger, DM., Vila-Rodriguez, F., Wang, W., et al.[2022]

Intermittent theta burst stimulation (iTBS) is as effective as standard high-frequency (10 Hz) rTMS for treating treatment-resistant depression, showing non-inferiority in improving depression scores over 4-6 weeks in a study with 414 participants.

Both iTBS and 10 Hz rTMS had similar safety profiles and dropout rates, with headaches being the most common side effect, indicating that iTBS can be a viable alternative that allows for more patients to be treated in a shorter time without losing effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Blumberger, DM., Vila-Rodriguez, F., Thorpe, KE., 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]

Intermittent theta burst stimulation (iTBS) is a cost-effective alternative to conventional 10Hz rTMS for treating depression, with an average treatment cost of $1,108 compared to $1,844 for 10Hz rTMS, resulting in savings of $735 per patient.

iTBS also shows a lower average cost per remission at $3,695, compared to $6,146 for 10Hz rTMS, leading to significant savings of $2,451 per remission, making it a more efficient treatment option in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of intermittent theta burst stimulation compared to conventional repetitive transcranial magnetic stimulation in patients with treatment resistant depression: A cost analysis. Mendlowitz, AB., Shanbour, A., Downar, J., et al.[2020]

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 26 patients with bipolar depression, active intermittent theta burst stimulation (iTBS) showed a high response rate of 72% and a remission rate of 42%, indicating its potential efficacy in treating this condition.

No adverse events were reported, demonstrating that iTBS is safe and well-tolerated, but further research with larger sample sizes is needed to confirm its superiority over sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. Bulteau, S., Beynel, L., Marendaz, C., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intermittent theta burst stimulation versus high-frequency repetitive transcranial magnetic stimulation for patients with treatment-resistant depression: a systematic review. [2023]

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

A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. [2022]

4. 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]

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

Implementation of intermittent theta burst stimulation compared to conventional repetitive transcranial magnetic stimulation in patients with treatment resistant depression: A cost analysis. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

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

7. France pubmed.ncbi.nlm.nih.gov

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. [2020]