Deep TMS for Depression

Not currently recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new protocol using Deep Transcranial Magnetic Stimulation (Deep TMS) to treat Major Depressive Disorder (MDD). The goal is to determine if this new method is as safe and effective as the current standard treatment. Individuals with depression that hasn't responded well to antidepressants and who have experienced their current depressive episode for more than four weeks but less than five years might be suitable candidates. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance future treatment options for depression.

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 prior data suggests that the BrainsWay Deep TMS device is safe for treating Major Depressive Disorder?

Research has shown that Accelerated Intermittent Theta Burst Stimulation (iTBS) Deep Transcranial Magnetic Stimulation (Deep TMS) is generally safe for treating depression. Studies have found that iTBS can reduce symptoms of depression and anxiety, with side effects similar to other TMS treatments. These side effects are usually mild, such as headaches or scalp discomfort, and they tend to resolve over time.

One study highlighted that iTBS is a non-invasive method, meaning it doesn't require surgery, and it works quickly to improve mood in people with Major Depressive Disorder (MDD). This suggests that most patients tolerate the treatment well.

Overall, research supports that iTBS Deep TMS is a promising and safe option for people dealing with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the investigational deep TMS protocol for depression because it utilizes accelerated Intermittent Theta Burst Stimulation (iTBS), which is a cutting-edge technique. Unlike traditional TMS treatments that can take several weeks to show effectiveness, iTBS has the potential to deliver faster results, potentially within days. This quicker response time is especially promising for individuals seeking rapid relief from depressive symptoms. Additionally, the investigational protocol might offer a more precise stimulation method, aiming to enhance treatment outcomes while maintaining safety.

What evidence suggests that the BrainsWay Deep TMS device is effective for treating Major Depressive Disorder?

Research has shown that Accelerated Intermittent Theta Burst Stimulation (iTBS) can help reduce symptoms of major depressive disorder (MDD). In this trial, participants in the investigational stimulation group will receive the new investigational deep TMS protocol, which includes iTBS. One study found that iTBS was more effective than a placebo for patients whose depression did not improve with other treatments. Other research suggests that iTBS acts quickly to relieve depression, offering hope for those with MDD. Additionally, Theta Burst Stimulation (TBS) in general is considered more efficient and possibly more effective than traditional methods. These findings strongly support iTBS as a promising treatment for depression. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38985492/

Accelerated Intermittent Theta-Burst Stimulation and ... In this randomized clinical trial, aiTBS was more effective than sham stimulation for depressive symptom reduction in patients with treatment-resistant BD.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123003797

Accelerated intermittent theta burst stimulation in major ... aiTBS is a promising form of non-invasive brain stimulation [NIBS] with rapid antidepressant and antisuicidal effects in major depressive disorder [MDD].

3. nature.com nature.com/articles/s41380-024-02630-5

Theta burst stimulation for depression: a systematic review ... Theta burst stimulation (TBS) presents as a more efficient and potentially more effective therapeutic modality than conventional repetitive transcranial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05849402

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in ... The aim of this study is to assess the efficacy of aiTBS applied to the left dorsolateral prefrontal cortex (L-DLPFC) in reducing depressive symptoms in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10773082/

A randomized sham-controlled trial of high-dosage ... A randomized sham-controlled trial of high-dosage accelerated intermittent theta burst rTMS in major depression: study protocol · Background and ...

6. 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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841443/

A meta-analysis comparing the effectiveness and safety of ... Both rTMS and TBS are similarly effective in reducing depression and anxiety symptoms, with comparable side effect profiles.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322325013563

Efficacy and Safety of Accelerated Intermittent Theta-burst ... Several systematic reviews have supported TMS as a potentially effective treatment option for adolescents with MDD, suggesting that high- ...