Transcranial Magnetic Stimulation for Major Depressive Disorder

(rmPFC-Savoring Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Florida State University

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brain stimulation treatment to determine if it can help people with major depressive disorder enjoy positive experiences more. The technique, called transcranial magnetic stimulation (TMS), sends magnetic pulses to specific brain areas to assess its effect on reward processing. Specifically, the trial uses Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation, a form of TMS. Participants will have their brain activity monitored while performing tasks designed to test this. Suitable candidates for the trial are right-handed individuals who currently experience major depressive disorder and often struggle to enjoy positive moments. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on innovative treatments for depression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that transcranial magnetic stimulation is safe for individuals with depression?

Studies have shown that transcranial magnetic stimulation (TMS), particularly the accelerated intermittent theta burst (iTBS) method, is generally safe for treating major depressive disorder. Research indicates that this treatment can quickly and effectively reduce depressive symptoms without major side effects.

The iTBS method has been compared to other TMS techniques and is considered safe. The FDA has approved it for severe depression, confirming it has passed important safety tests. Some studies have also explored targeting different brain areas, such as the rostromedial prefrontal cortex, and found it to be well-tolerated.

In summary, for those considering joining a TMS trial, existing research supports its safety and effectiveness in treating depression.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore new brain regions and mechanisms to tackle depression. Unlike standard depression treatments like medication or traditional TMS, this trial uses accelerated intermittent theta burst stimulation, which is a quicker form of transcranial magnetic stimulation. The focus on the left rostromedial prefrontal cortex is unique because it targets reward sensitivity and positive affect, which could lead to new ways of enhancing mood and emotional processing. Additionally, the trial compares this to a more traditional TMS target, the left dorsolateral prefrontal cortex, and a placebo, which helps determine the specific impact of these brain areas on depression.

What evidence suggests that this trial's treatments could be effective for major depressive disorder?

This trial will compare different applications of accelerated intermittent theta burst transcranial magnetic stimulation (a-iTBS) for major depressive disorder (MDD). Studies have shown that a-iTBS can quickly and effectively reduce symptoms of depression in people with MDD. For some patients, up to 66.7% respond well to the treatment, and up to 57.1% experience complete relief from symptoms. However, results can vary, and some studies show mixed outcomes. Overall, a-iTBS is considered a promising option, especially for those who haven't found success with standard treatments. Participants in this trial will receive a-iTBS targeting either the left dorsolateral prefrontal cortex, the left rostromedial prefrontal cortex, or the left primary somatosensory cortex as a placebo intervention.13678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who currently have major depressive disorder, are right-handed, speak English, can see normally (with or without correction), and have a low suicide risk. Participants must be willing to attend all sessions and follow study procedures.

Inclusion Criteria

I am between 18 and 65 years old.
* Willing to comply with all study procedures and be available for the duration of the study
* Acceptable suicide risk as determined by less than 5 on the Depression Symptom Index Suicidality Subscale (DSI-SS)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Clinical Assessment

Participants undergo a clinical assessment to establish baseline measures

1 week
1 visit (in-person)

EEG Recording

EEG recording during reward tasks after participants learn/practice positive savoring

1 week
1 visit (in-person)

fMRI Session

Participants undergo an fMRI session to record brain activity

1 week
1 visit (in-person)

TMS Session

TMS session combined with EEG while participants practice positive savoring and perform reward tasks

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in neural and behavioral responses to rewards

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation

Trial Overview

The study tests whether non-invasive brain stimulation (TMS) targeting the prefrontal cortex can improve how people with depression experience positive emotions. Brain activity will be measured using EEG and MRI during reward-related tasks over four sessions.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta BurstExperimental Treatment1 Intervention
Group II: Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta BurstActive Control1 Intervention
Group III: Left Primary Somatosensory Cortex - Accelerated Intermittent Theta BurstPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+

Citations

Efficacy and safety of intermittent theta-burst stimulation ... - PMC

Accelerated cTBS demonstrated superior anxiolytic (1 RCT) and anti-suicidal efficacy (1 RCT) compared to accelerated iTBS in MDD, with similar ...

Efficacy and Safety of Accelerated Intermittent Theta Burst ...

Conclusions. a-iTBS was a safe and effective treatment for adolescents with non–treatment-resistant MDD, but the therapeutic effect diminished ...

Accelerated Theta Burst Stimulation Transcranial Magnetic ...

The Pururauka accelerated iTBS protocol was associated with rapid and sustained reductions in depressive symptoms and suicidal ideation in ...

Accelerated Intermittent Theta Burst Stimulation for ...

This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients. A small pilot study (n=22) will ...

Assessing the clinical effects of accelerated iTBS across ...

The goal of this study was to assess the feasibility and efficacy of personalized, connectivity-guided, accelerated intermittent theta-burst ...

Causal Role of Rostromedial Prefrontal Cortex for Positive ...

Accelerated intermittent theta burst will be delivered to left dorsolateral prefrontal cortex, which is considered "treatment as usual" for depression.

Accelerating the Therapeutic Effects of Non-invasive Brain ...

Major Depressive Disorder. Accelerated TMS (aTMS) is most extensively studied in MDD and has achieved regulatory clearance and clinical billing ...

Efficacy and safety of intermittent theta burst stimulation ...

The objective of this systematic review was to compare the safety and efficacy of iTBS and high-frequency (≥ 5 Hz) rTMS (HF-rTMS) for patients with treatment- ...