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RecruitingNCT05849402

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolarity type II

This study is recruiting. It focuses on depression and currently lists participation information in the United States.

Depression, BipolarityDeviceFrom 18 Years to 80 Years
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Study ID: NCT05849402. We help you review the study, but cannot decide medical eligibility.
In plain English

Key information made simple

What is this study testing?

This study is testing whether Active Comparator: Active aiTBS may be useful for adults experiencing depression.

What would participation involve?

Participants may use Active Comparator: Active aiTBS, complete questionnaires or follow-up assessments. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in United States.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about whether participation can be remote and what device access is needed, whether there is placebo, randomization, or a comparison group, whether remote participation is possible, the exact eligibility criteria.

What to expect

Your next step

Participation is in person at Stanford University in Palo Alto, California. The treatment course is intensive: 10 aiTBS sessions a day for 5 consecutive days, with either active or sham stimulation. Before and after the treatment course, participants complete depression and mania assessments, and the study also collects MRI, EEG, and heart-rate-variability data. Key fit points include being 18 to 80, having Bipolarity type II in a current major depressive episode, meeting treatment-resistance criteria, being TMS-naive, having a stable psychiatrist, and staying on a mood stabilizer during the study. Common exclusions include pregnancy, seizure history, metal implants or pacemakers, current psychosis or hypomania, active suicidal risk, recent ketamine or ECT, and some cardiac or substance-use concerns.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: December 20, 2022
Recruitment status
Recruiting
Estimated enrollment
Not clearly listed
Sponsor
Stanford University
Sponsor type
University
Study type
Device
Intervention type
DEVICE
Study phase
Not clearly listed
Locations
United States
Age range
From 18 Years to 80 Years
Official registry ID
NCT05849402
Official title
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
Official source
Official registry link

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Study ID: NCT05849402. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring brain stimulation for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. It includes a comparison with a sham comparison. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a device, app, or technology?

This appears to be a device / app / digital / technology study involving Active Comparator: Active aiTBS, Sham Comparator: Sham aiTBS. The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.

Do I need to want to stop or reduce tobacco use to participate?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

What would I likely need to do?

You may need to use a device, app, or digital tool for a defined period. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What should I check about data, monitoring, alerts, and daily use?

If the study uses a device, app, or digital tool, check what data is collected, who can access it, how often you need to use it, and what happens if the tool detects a concerning signal. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Stanford University, which appears to be a university. The listed contact or investigator is Stanford University, affiliated with Stanford University. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is currently recruiting. This does not mean you are eligible: the study team must confirm the criteria, available locations, and next steps.

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