60 Participants Needed

Transcranial Magnetic Stimulation for Bipolar Disorder

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AW
Overseen ByAlexis Worthley, BA
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication has been stable for at least 3 months before participating.

Is Transcranial Magnetic Stimulation (TMS) safe for humans?

A pilot study on TMS for depression in bipolar disorder found it to be safe, focusing on the left prefrontal area of the brain. This suggests that TMS is generally safe for humans, even though it is not yet FDA approved for bipolar disorder specifically.12345

How is transcranial magnetic stimulation (TMS) different from other treatments for bipolar disorder?

Transcranial magnetic stimulation (TMS) is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which is different from traditional drug treatments like lithium. It is particularly unique because it offers an alternative for those who do not respond well to medications, and it has shown promise in treating bipolar depression, although more research is needed to confirm its effectiveness.12678

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation (TMS) for Bipolar Disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is effective for treating depression, including in people with bipolar disorder. Studies indicate that patients with bipolar disorder benefit from rTMS similarly to those with unipolar depression, and it may be particularly effective in reducing paranoia symptoms in bipolar patients.12479

Who Is on the Research Team?

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Kristen Ellard, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with bipolar mood disorders who struggle to regulate their emotions. Healthy individuals without psychiatric conditions, as confirmed by an interview, and who score below 80 on the Emotion Regulation Scale can also participate.

Inclusion Criteria

You have never been diagnosed with a mental health disorder after being assessed with the MINI.
Your ability to manage and control your emotions will be assessed using a scale called the DERS. If you score less than 80 on this scale, it means that you have normal levels of emotion regulation.
Requirements for people who are healthy and will be used as a comparison group in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Control Group Assessment

Healthy control subjects undergo fMRI scanning while performing emotion regulation tasks to establish a normative sample.

2 weeks
1 visit (in-person)

Phase 2 - Patient Group Assessment and Treatment

Patients with bipolar disorder perform emotion regulation tasks during fMRI scanning, followed by TMS sessions targeting individualized brain regions.

2 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after TMS treatment, with assessments of behavior, neural activation, and functional connectivity.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TMS
Trial Overview The study is testing whether Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, can improve emotion regulation in people with bipolar disorder.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Bipolar GroupExperimental Treatment1 Intervention
Group II: Healthy ControlActive Control1 Intervention

TMS is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Transcranial Magnetic Stimulation for:
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Approved in European Union as Transcranial Magnetic Stimulation for:
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Approved in Canada as Transcranial Magnetic Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has shown a higher clinical response rate in treating bipolar depression compared to sham treatment, with an odds ratio of 2.72 based on data from 274 patients across 14 studies.
Significant clinical response was specifically noted with high-frequency rTMS targeting the left dorsolateral prefrontal cortex, indicating a potential effective treatment approach, although more large-scale studies are needed to confirm these findings.
The efficacy of repetitive transcranial magnetic stimulation (rTMS) for bipolar depression: A systematic review and meta-analysis.Nguyen, TD., Hieronymus, F., Lorentzen, R., et al.[2021]
In a study of 40 patients with mixed episodes of bipolar disorder, low-frequency rTMS (1Hz) applied to the right Dorsolateral Prefrontal Cortex showed a 46.6% responder rate for depressive symptoms, with 28.6% achieving remission.
The treatment also demonstrated a 15% responder rate for manic symptoms, indicating that LF-rTMS may be an effective augmentation strategy for managing both depressive and manic symptoms in mixed states of bipolar disorder.
rTMS in resistant mixed states: an exploratory study.Pallanti, S., Grassi, G., Antonini, S., et al.[2018]
In a follow-up study of 11 drug-resistant depressed bipolar patients, those who achieved remission after acute rTMS treatment were more likely to maintain their improvement after one year, indicating the long-term efficacy of rTMS.
Conversely, patients who did not respond to rTMS initially were unlikely to experience any long-term benefits, suggesting that early response is crucial for predicting sustained outcomes.
Long-term efficacy after acute augmentative repetitive transcranial magnetic stimulation in bipolar depression: a 1-year follow-up study.Dell'osso, B., D'Urso, N., Castellano, F., et al.[2022]

Citations

The efficacy of repetitive transcranial magnetic stimulation (rTMS) for bipolar depression: A systematic review and meta-analysis. [2021]
rTMS in resistant mixed states: an exploratory study. [2018]
Long-term efficacy after acute augmentative repetitive transcranial magnetic stimulation in bipolar depression: a 1-year follow-up study. [2022]
Repetitive transcranial magnetic stimulation (rTMS) in bipolar disorder: A systematic review. [2023]
Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Bipolar Disorder in Comparison to the Treatment of Unipolar Depression in a Naturalistic Setting. [2022]
Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. [2019]
Do bipolar disorder soft signs impact outcomes following Transcranial Magnetic Stimulation (TMS) therapy for depression? [2020]
Repetitive Transcranial Magnetic Stimulation in the Treatment of Bipolar Disorder. [2023]
Augmentative transcranial magnetic stimulation (TMS) combined with brain navigation in drug-resistant rapid cycling bipolar depression: a case report of acute and maintenance efficacy. [2009]
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