Personalized Neuromodulation for Treatment-Resistant Depression

JT
Overseen ByJade T Truong, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
Must be taking: Antidepressants
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 a brain stimulation treatment called intermittent theta burst stimulation (iTBS) for individuals with treatment-resistant depression. Researchers are testing whether customizing iTBS settings based on specific brain signals for each person is more effective than using uniform settings or a placebo treatment. Individuals with moderate-to-severe depression who have not found success with other treatments may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to more personalized and effective depression treatments.

Will I have to stop taking my current medications?

You can either stay on your current antidepressant medication or be medication-free for at least 4 weeks before and during the study.

What prior data suggests that this brain stimulation treatment is safe for individuals with treatment-resistant depression?

Research has shown that intermittent theta burst stimulation (iTBS) is generally well-tolerated by people with treatment-resistant depression. Studies have found that iTBS shares a safety profile with high-frequency repetitive transcranial magnetic stimulation (rTMS), meaning its side effects are usually mild and temporary, such as mild headaches and discomfort at the stimulation site.

Previous studies demonstrated that iTBS is as safe as the standard 10 Hz rTMS treatment, which the FDA has already approved for depression. This provides reassurance about iTBS's safety. Whether customized for the individual or not, iTBS has shown similar safety results, with no significant increase in negative effects reported. While the safety data is encouraging, individual experiences with side effects may vary, so discussing any personal concerns with a healthcare provider is important.12345

Why are researchers excited about this trial?

Researchers are excited about the use of Intermittent Theta Burst Stimulation (iTBS) for treatment-resistant depression because it offers a personalized approach that could be more effective than existing options like antidepressants or electroconvulsive therapy. Unlike standard treatments, personalized iTBS tailors the stimulation parameters to each individual, potentially leading to better outcomes by targeting the unique brain activity patterns of each patient. Additionally, this method is non-invasive and could provide quicker relief from symptoms compared to traditional therapies, which often take weeks to show results. The use of a sham comparator and a non-personalized iTBS arm in the trial also helps researchers understand the added benefits of personalization.

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

Studies have shown that intermittent theta burst stimulation (iTBS) effectively treats depression. Research indicates that iTBS can quickly improve symptoms, even in individuals unresponsive to other treatments. A review of studies found that iTBS works as well as high-frequency repetitive transcranial magnetic stimulation (rTMS). In this trial, participants may receive Personalized iTBS, which adjusts treatment based on individual brain responses to enhance effectiveness. Early findings suggest that customizing iTBS settings using brain signals could yield better results than standard methods. Other participants will receive Non-Personalized iTBS with standard parameters or Sham iTBS for comparison.35678

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 adults aged 18-65 with moderate-to-severe major depression that hasn't improved with standard treatments. Participants must be able to understand English, keep their medication stable or stay off meds, and not have other main psychiatric conditions or high suicide risk.

Inclusion Criteria

I am currently experiencing moderate to severe depression.
Able to comprehend English sufficiently to complete study procedures and assessments
I am between 18 and 65 years old.
See 3 more

Exclusion Criteria

High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Primary psychiatric diagnosis other than MDD
Contraindications to MRI (e.g., implanted metal)
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to approximately 3 weeks
3 screening days

Treatment

Participants receive 10 sessions of iTBS using either personalized or non-personalized settings, or sham iTBS

10 hours per testing day
10 sessions

Follow-up

Participants are monitored for changes in depression and anxiety symptoms, as well as cognitive performance

Up to approximately 7 weeks
End of each testing day

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Theta Burst Stimulation (iTBS)

Trial Overview

The study compares three types of brain stimulation: personalized iTBS (tailored using EEG signals), standard iTBS, and a sham (inactive) version. The goal is to see if customizing the treatment improves outcomes in people with hard-to-treat depression.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Personalized iTBSExperimental Treatment1 Intervention
Group II: Non-Personalized iTBSActive Control1 Intervention
Group III: Sham iTBSPlacebo Group1 Intervention

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

The antidepressant effect of intermittent theta burst stimulation ...

The aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients.

Efficacy study of intermittent theta burst stimulation(iTBS) in ...

The current study suggests that two days of active iTBS to the DLPFC region can rapidly, safely, and effectively improve depressive symptoms in adolescents ...

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

While anxious depression is associated with poorer treatment outcomes, adjunctive rTMS has shown significant anxiety reduction in such patients ...

A randomized non-inferiority clinical trial - Brain Stimulation

Our study could not establish the non-inferiority of BL-TBS compared to BL-rTMS in terms of efficacy for patients with TRD across the adult lifespan. Keywords.

Theta burst stimulation for depression: a systematic review ...

The current study outcomes included the response rate (primary), depression symptom improvement, remission rate, all-cause discontinuation rate, ...

Accelerated Theta Burst Stimulation (aTBS): Safety, efficacy ...

A large, multicenter clinical trial found iTBS had equivalent antidepressant efficacy to 10Hz rTMS and consequently iTBS was FDA-approved for the treatment of ...

Efficacy and Safety of Accelerated Intermittent Theta Burst ...

a-iTBS was a safe and effective treatment for adolescents with non–treatment-resistant MDD, but the therapeutic effect diminished at the 3-month ...

E-field Guided iTBS for Treatment Resistant Depression

The purpose of this study is to establish how personalization of rTMS can change markers of brain activity and improve treatment response in major depressive ...