rTMS for Bipolar Disorder
(CircuitBD 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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Phase 1
Participants receive either active rTMS or sham rTMS for 5 days
Washout Period
A variable washout period between intervention phases
Intervention Phase 2
Participants receive the alternate rTMS treatment (active or sham) for 5 days
Follow-up
Participants are monitored for changes in depression and functional connectivity
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
Sham rTMS (no active TMS pulses) administered during Intervention Phase 1; Active rTMS administered during Intervention Phase 2. Participants will undergo two 5-day rTMS intervention phases (5 days of sham stimulation followed by 5 days of active stimulation) separated by a variable 4-12 week washout period.
Active rTMS administered during Intervention Phase 1; Sham rTMS (no active TMS pulses) administered during Intervention Phase 2. Participants will undergo two 5-day rTMS intervention phases (5 days of active stimulation followed by 5 days of sham stimulation) separated by a variable 4-12 week washout period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
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 ...
2.
digitalcommons.pcom.edu
digitalcommons.pcom.edu/cgi/viewcontent.cgi?article=1588&context=pa_systematic_reviewsIs Transcranial Magnetic Stimulation (TMS) an Effective ...
High-frequency repetitive transcranial magnetic stimulation (rTMS) improves neurocognitive function in bipolar disorder. J Affect. Disord ...
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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