Individualized TMS for Depression

(AINT Trial)

DH
Overseen ByDania Haj-Darwish, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called accelerated intermittent theta burst stimulation (aiTBS) for individuals with major depressive disorder, a type of depression that resists usual treatments. The researchers aim to determine if brain scans can guide the treatment more effectively than standard head measurements. Participants will receive aiTBS without knowing which method determined their treatment spot. This trial suits individuals with major depression that hasn't improved despite consistent medication use for at least four weeks. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early findings.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. You need to have a stable antidepressant medication regimen for 4 weeks before the treatment and stay on it throughout the study.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must have a stable antidepressant medication regimen for 4 weeks before the trial and continue it throughout the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that accelerated intermittent theta burst stimulation (aiTBS) is generally safe and well-tolerated. Studies have found that aiTBS, used to treat depression, does not cause major side effects. This treatment stimulates the brain externally, eliminating the need for surgery. Recipients of aiTBS reported rapid improvements in depression symptoms. Although further research is needed, current evidence suggests that aiTBS is a safe option for those considering this treatment.12345

Why do researchers think this study treatment might be promising for depression?

Researchers are excited about aiTBS for depression because it offers a personalized approach by using neuronavigation based on each individual's brain connectivity patterns. Unlike traditional depression treatments, which often involve medication or standard repetitive transcranial magnetic stimulation (rTMS), aiTBS targets specific brain areas identified through resting state functional connectivity. This could lead to more effective and faster results by precisely delivering magnetic pulses to the most relevant brain regions. Moreover, the use of aiTBS with neuronavigation aims to enhance the precision and efficacy of treatment, potentially reducing side effects and improving outcomes for individuals with depression.

What evidence suggests that this trial's aiTBS treatments could be effective for depression?

Research shows that accelerated intermittent theta burst stimulation (aiTBS) could benefit people with major depressive disorder. Studies have found that aiTBS can quickly reduce depression and suicidal thoughts in individuals whose depression hasn't improved with other treatments. In this trial, participants will receive either real aiTBS with neuronavigation to a treatment target identified through individualized resting state functional connectivity or a sham version using head measurements. One study found that a high-dose version of aiTBS, guided by brain imaging, was safe and easy for patients to handle. Another study showed that aiTBS could be as effective as traditional brain stimulation treatments, but in a much shorter time. Overall, aiTBS offers a fast-acting option for those dealing with severe depression.12346

Who Is on the Research Team?

JJ

Joseph J Taylor, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults with major depressive disorder who haven't responded well to other treatments. They must speak English, maintain their usual caffeine intake, not use tobacco on treatment days, and avoid alcohol before MRI and TMS sessions. Pregnant individuals or those trying to become pregnant cannot participate.

Inclusion Criteria

I have been diagnosed with major depression.
I have not changed my antidepressant medication or been off it for the last 4 weeks.
Abstain from becoming pregnant from screening through end of treatment
See 9 more

Exclusion Criteria

Anyone presenting with psychosis
Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
Severe borderline personality disorder
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated intermittent theta burst stimulation (aiTBS) with either real or sham individualized resting state functional connectivity targeting

1 week
Multiple daily treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI scans and various psychological assessments

12 months
Regular assessments at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • aiTBS
Trial Overview The study tests aiTBS (a type of brain stimulation) for depression treatment effectiveness. Participants will receive aiTBS without knowing if the targeted area was chosen using neuroimaging or standard head measurements.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: sham individualized resting state functional connectivity targetingExperimental Treatment1 Intervention
Group II: real individualized resting state functional connectivity targetingExperimental Treatment1 Intervention

aiTBS is already approved in United States for the following indications:

🇺🇸
Approved in United States as aiTBS for:

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Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Published Research Related to This Trial

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.
Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial.Chen, L., Thomas, EHX., Kaewpijit, P., et al.[2022]
Intermittent theta burst stimulation (iTBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) are equally effective and safe for treating patients with treatment-resistant major depressive disorder, based on a comprehensive meta-analysis.
iTBS may be a more practical option in clinical settings because it requires less stimulation intensity and shorter treatment times compared to HF-rTMS, making it potentially more accessible for patients.
Intermittent theta burst stimulation vs. high-frequency repetitive transcranial magnetic stimulation for major depressive disorder: A systematic review and meta-analysis.Kishi, T., Sakuma, K., Matsuda, Y., et al.[2023]
In a study of 60 patients with treatment-resistant unipolar depression, both intermittent theta burst stimulation (iTBS) and conventional 10 Hz rTMS showed similar efficacy in reducing depression scores and improving quality of life over a 6-month follow-up, with response rates of 36.7% for iTBS and 33.3% for rTMS.
iTBS is highlighted as a more time-efficient and cost-effective option compared to rTMS, suggesting it could be a valuable treatment alternative for patients with severe depression who have not responded to multiple antidepressant trials.
Intermittent theta burst stimulation (iTBS) versus 10 Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) to alleviate treatment-resistant unipolar depression: A randomized controlled trial (THETA-DEP).Bulteau, S., Laurin, A., Pere, M., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32252538/
Stanford Accelerated Intelligent Neuromodulation Therapy for ...SAINT, an accelerated, high-dose, iTBS protocol with fcMRI-guided targeting, was well tolerated and safe. Double-blinded sham-controlled trials are needed.
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].
Study Details | NCT03240692 | Stanford Accelerated ...This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In ...
Stanford Accelerated Intelligent Neuromodulation TherapyA recently completed non-inferiority trial demonstrated that 600 pulses of iTBS (3 min protocol) is non-inferior to 3,0000 pulses of 10hz. rTMS (37 min protocol) ...
Accelerated Intermittent Theta-Burst Stimulation and ...This randomized clinical trial assesses the effectiveness of accelerated intermittent theta-burst stimulation for depressive symptom reduction
Stanford Accelerated Intelligent Neuromodulation Therapy ...SAINT, an accelerated, high-dose, iTBS protocol with fcMRI-guided targeting, was well tolerated and safe. Double-blinded sham-controlled trials are needed.
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