145 Participants Needed

Optimized TMS for Depression

(TARGET Trial)

Recruiting at 1 trial location
JT
Overseen ByJade T Truong, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance depression treatment by identifying reliable brain activity markers through a technique called TARGET. Participants will receive various types of Transcranial Magnetic Stimulation (TMS), a non-invasive method using magnetic fields to stimulate brain nerve cells. The trial suits individuals with moderate-to-severe depression who haven't experienced neurological disorders or seizures. It also includes neurosurgical patients with epilepsy to explore effects during brain monitoring. As an unphased trial, this study allows participants to contribute to groundbreaking research that could improve future depression treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that lower the seizure threshold, like olanzapine, chlorpromazine, or lithium.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that transcranial magnetic stimulation (TMS), the treatment being tested in this trial, is generally easy for people to handle. Studies have found that TMS has very few side effects, making it a safe choice for many patients. The FDA has already approved it for treating major depression, which supports its safety. Most people who try TMS experience only mild side effects, such as headaches or lightheadedness, which usually resolve quickly. This evidence suggests that the TMS methods in this trial are expected to be safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the TARGET optimized TMS for depression because it offers a more personalized approach compared to standard repetitive TMS. Traditional treatments like antidepressants and conventional TMS can take weeks to show effects and may not work for everyone. However, TARGET TMS uses real-time feedback with EEG to tailor the stimulation specifically to the dlPFC, potentially enhancing effectiveness and reducing time to response. This method aims to improve precision and outcomes by adjusting the treatment to each individual's brain activity, which could lead to faster and more reliable relief of depressive symptoms.

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

Research shows that transcranial magnetic stimulation (TMS) effectively treats depression. Studies have found that applying TMS to both sides of the brain at a faster pace can significantly improve depression symptoms. For example, one study found that half of the participants experienced long-lasting relief from depression after treatment. Another study demonstrated that TMS quickly reduced depressive symptoms. This trial will compare different TMS methods, including TARGET optimized TMS and non-optimized TMS, to evaluate their effectiveness in treating depression. These advanced TMS methods might effectively treat depression by targeting specific brain areas that control mood.46789

Who Is on the Research Team?

CJ

Corey J Keller, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with Major Depressive Disorder who have not responded well to standard treatments. Participants must be eligible for brain imaging and TMS procedures, but cannot join if they have metal implants in their head, seizure disorders, or are currently pregnant.

Inclusion Criteria

In a current depressive episode, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)
Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
I have moderate-to-severe depression based on my QIDS score.
See 5 more

Exclusion Criteria

Those with a contraindication for MRIs (e.g. implanted metal)
Any unstable medical condition
Active substance abuse
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-pulse TMS (both optimized and non-optimized) and sham TMS with concurrent EEG or iEEG recording

6 hours
1 visit (in-person)

Follow-up

Participants are monitored for changes in TMS-Evoked Potentials (TEP) and iTEP amplitude

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TARGET

Trial Overview

The study tests different types of Transcranial Magnetic Stimulation (TMS) therapy: non-optimized vs TARGET-optimized TMS. It also uses EEG and iEEG recordings to measure brain activity and aims to find better ways to treat depression by adjusting brain excitability.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Sham TMS, Active TMS with iEEGExperimental Treatment3 Interventions
Group II: Optimized TMS, Non-optimized TMS with EEGExperimental Treatment3 Interventions
Group III: Non-optimized TMS, Optimized TMS with EEGExperimental Treatment3 Interventions
Group IV: Active TMS, Sham TMS with iEEGExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Optimization Strategies of Transcranial Magnetic ...

Bilateral rTMS and accelerated rTMS are promising techniques for treating MDD. A meta-analysis reported that bilateral rTMS is a potentially effective treatment ...

Real-world effectiveness of a single-day regimen for ...

At week 26, 16/32(50 %) showed sustained remission on HDRS-17 and BDI-II; relapse/retreatment had occurred in 25 % on HDRS-17 and 28.1 % on BDI-II. This ...

Accelerated TMS - moving quickly into the future of ...

Overall, accelerated TMS appears to hold promise to reduce treatment time and achieve rapid reduction in depressive symptoms, but at this time ...

Accelerated TMS to a Novel Brain Target in MDD and PTSD

This is a Clinical Trial designed to evaluate novel transcranial magnetic stimulation (TMS) methods for treating depression/PTSD. TMS is an FDA-approved ...

Daily Left Prefrontal Transcranial Magnetic Stimulation ...

Minimal adverse effects did not differ by treatment arm, with an 88% retention rate (90% sham and 86% active). Primary efficacy analysis revealed a significant ...

Accelerated repetitive transcranial magnetic stimulation in ...

rTMS treatment is generally well tolerated, with a very low incidence of treatment-emergent adverse effects [8]. The use of accelerated Deep TMS ...

Efficacy, effectiveness and safety of transcranial magnetic ...

Our results confirm a clear and significant effect of TMS on depressive symptom severity in patients with BDep, similar to what has been found ...

Accelerated TMS to a Novel Brain Target in MDD and PTSD

This is a Clinical Trial designed to evaluate novel transcranial magnetic stimulation (TMS) methods for treating depression/PTSD. TMS is an FDA-approved ...

Status and trends of TMS research in depressive disorder

This study aims to employ bibliometric methods to systematically review the global research status and trends of TMS in depression.