RecruitingNot ApplicableNCT05849402

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder


Sponsor

Stanford University

Enrollment

60 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the effectiveness of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) in inducing anti-depressant responses in individuals with treatment-resistant depression of bipolar II disorder. This is a double-blind, randomized, sham-controlled trial that targets a single location on the left dorsolateral prefrontal cortex (LDLPFC) using the MagPro rTMS system.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of brain stimulation called accelerated intermittent theta-burst stimulation (aiTBS) — a non-invasive procedure that uses magnetic pulses to stimulate areas of the brain — to treat depression in people with bipolar II disorder who haven't responded to standard treatments. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with bipolar II disorder and are currently in a major depressive episode - Your depression has not adequately responded to antidepressant medications - You are not currently in a manic or hypomanic episode **You may NOT be eligible if...** - You have a history of seizures or epilepsy - You have metal implants in or near your head (like a cochlear implant or certain aneurysm clips) - You are pregnant - You have had brain surgery or have significant neurological conditions - You have recently started or changed psychiatric medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive Comparator: Active aiTBS

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

DEVICESham Comparator: Sham aiTBS

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.


Locations(1)

Stanford University

Palo Alto, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05849402


Related Trials