62 Participants NeededMy employer runs this trial

rTMS for Bipolar Disorder

(CircuitBD Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) for treating depression in individuals with bipolar disorder. The researchers aim to determine if rTMS can improve mood by targeting specific brain areas associated with mood changes. Participants will undergo two types of rTMS sessions: one with active magnetic pulses and another with sham (inactive) pulses. Suitable participants should have a diagnosis of bipolar disorder and experience moderate depression, with or without stable medication. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

What is the safety track record for repetitive transcranial magnetic stimulation (rTMS)?

A previous study demonstrated that repetitive transcranial magnetic stimulation (rTMS) is safe and well-tolerated for treating depression. This technique uses magnetic pulses to stimulate specific brain areas and is non-invasive, meaning it doesn't involve surgery or entering the body.

The FDA has already approved rTMS for treating depression, which reassures about its safety. Recipients of rTMS often report mild side effects like headaches or feeling lightheaded. These effects are usually temporary and subside after the session.

Since this study is in the later stages of research (Phase 4), rTMS has already undergone testing in earlier studies where researchers closely monitored safety. This indicates that the treatment is generally safe for use in humans.12345

Why are researchers enthusiastic about this study treatment?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it offers a non-invasive approach to treating bipolar disorder by using magnetic fields to stimulate nerve cells in the brain. Unlike traditional treatments like mood stabilizers and antipsychotic medications, which can take weeks to show effectiveness and may have significant side effects, rTMS has the potential to quickly alleviate symptoms with fewer side effects. Researchers are excited about this treatment because it targets brain activity directly, which could offer a new way to manage bipolar disorder more efficiently and effectively.

What evidence suggests that rTMS might be an effective treatment for bipolar disorder?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can help reduce symptoms of bipolar depression. Studies have found that targeting specific brain areas with rTMS can lessen depressive symptoms in individuals with bipolar disorder. For example, one review found rTMS effective when aimed at the R-DLPFC brain area. Another study noted improvements in 35% of patients with bipolar depression who did not respond well to medication. Additionally, real-world data supports that rTMS is helpful and well-tolerated for treating bipolar depression. In this trial, participants will receive either active rTMS followed by sham rTMS or sham rTMS followed by active rTMS, allowing researchers to evaluate the effectiveness of rTMS in managing bipolar depression. Overall, these findings suggest that rTMS could be a promising option for managing bipolar depression.678910

Who Is on the Research Team?

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Immanuel Elbau, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with bipolar disorder who are currently experiencing depression. Participants must be able to undergo MRI scans and rTMS treatments, and should not have conditions or implants that make these procedures unsafe.

Inclusion Criteria

Provision of signed and dated informed consent form
Access to psychiatric care before, during, and after completion of the study
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
See 6 more

Exclusion Criteria

MRI contraindication including presence of foreign metal bodies or implants, implanted or conductive objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular implants, cochlear implants), permanent make-up
Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation
Abnormal bloodwork for electrolytes, thyroid, or liver function
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Participants receive either active rTMS or sham rTMS for 5 days

1 week
5 visits (in-person)

Washout Period

A variable washout period between intervention phases

4-12 weeks

Intervention Phase 2

Participants receive the alternate rTMS treatment (active or sham) for 5 days

1 week
5 visits (in-person)

Follow-up

Participants are monitored for changes in depression and functional connectivity

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

Researchers are testing whether targeted brain stimulation (rTMS) can improve mood in people with bipolar disorder. Each participant receives both real and placebo (sham) rTMS sessions in random order, guided by personalized brain scans.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sham rTMS followed by Active rTMSExperimental Treatment2 Interventions
Group II: Active rTMS followed by Sham rTMSExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

BD2 LLC

Collaborator

Citations

How Effective Is rTMS for Bipolar Depression?

By targeting and manipulating the left DLPFC, research suggests that rTMS potentially alleviates the depressive symptoms of bipolar disorder4 and improves ...

Is Transcranial Magnetic Stimulation (TMS) an Effective ...

High-frequency repetitive transcranial magnetic stimulation (rTMS) improves neurocognitive function in bipolar disorder. J Affect. Disord ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38495204/

Real-world retrospective study of repetitive transcranial ...

In conclusion, this retrospective study, using real-world TMS registry data, suggests that rTMS treatment for BD could be as effective as that ...

Repetitive transcranial magnetic stimulation in the ...

34. A previous review on the effectiveness of rTMS in. BD concluded that rTMS targeting the R-DLPFC, was effective at reducing symptoms of bipolar depression ...

Efficacy of repetitive transcranial magnetic stimulation in ...

These findings are in line with the results of observational studies, showing that 35% of patients with bipolar depression are medication ...

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