Personalized Neuromodulation for Treatment-Resistant Depression
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10 sessions of iTBS using either personalized or non-personalized settings, or sham iTBS
Follow-up
Participants are monitored for changes in depression and anxiety symptoms, as well as cognitive performance
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
Participants receive 10 sessions of iTBS using individually selected pulse count and intensity parameters identified during a prior screening phase as producing the greatest suppression of the EL-TEP biomarker.
Participants receive 10 sessions of iTBS using standard fixed parameters (1800 pulses, 120% resting motor threshold).
Participants receive 10 sessions of sham iTBS, matched in timing and scalp sensation to active stimulation using a shielded coil and scalp electrodes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.