MST for Bipolar Disorder

Overseen By Edison Leung, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edison Leung

Must not be taking: Antiepileptics, Benzodiazepines, Lithium

Disqualifiers: Implanted devices, Substance use, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Do I need to stop taking my current medications for the trial?

The trial requires you to be on a stable drug regimen of psychotropic medication for at least 6 weeks before starting. Some medications, like lithium, will be tapered off before the procedure. Antiepileptics and benzodiazepines are generally not allowed, but short or mid-acting benzodiazepines can be skipped 10 hours before procedures. Other medications with weak antiepileptic features will be reviewed and possibly adjusted by the study doctor.

What data supports the idea that MST for Bipolar Disorder is an effective treatment?

The available research shows that Magnetic Seizure Therapy (MST) is effective for treating depression, including in patients with bipolar disorder. One study reported successful MST treatment in a patient with bipolar disorder who had depression that didn't respond to other treatments. Compared to Electroconvulsive Therapy (ECT), MST had fewer side effects, such as less impact on memory and quicker recovery times. This suggests MST might be a good alternative to ECT for treating depression in bipolar disorder, with similar benefits but fewer negative effects. ^{1 2 3 4 5}

What safety data exists for MST/ECT in treating bipolar disorder?

Electroconvulsive therapy (ECT), which is related to Magnetic Seizure Therapy (MST), is generally considered a safe and effective treatment for psychiatric disorders, including bipolar disorder. However, it can have side effects such as anterograde amnesia, mania, post-ictal confusion, nausea, headache, myalgia, oral lacerations, and dental injuries. Rare complications like cardiovascular issues, post-stroke agitation, and epileptic status have been reported. There are also risks associated with the ECT procedure itself, such as skin burns and accidental mislocation of electrodes. Safety in patients with specific conditions, like multiple sclerosis, may require additional consideration due to potential neurological impacts and anesthesiological complications. ^{6 7 8 9 10}

Is MST a promising treatment for Bipolar Disorder?

Yes, MST is a promising treatment for Bipolar Disorder. It combines the benefits of ECT and transcranial magnetic stimulation, offering effective treatment with fewer cognitive side effects. MST has shown significant antidepressant effects and quicker recovery times compared to ECT. ^{1 2 3 11 12}

Research Team

Edison Leung, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults aged 22-85 with Bipolar Depression or Treatment Resistant Depression who are in good health and not pregnant. Participants must be on a stable medication regimen for at least 6 weeks, able to consent, use effective contraception, and have no history of seizures or severe psychiatric conditions like psychosis.

Inclusion Criteria

For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation and for an additional one week after the end of ECT/TMS administration

I am a man who can father children and will use contraception.

If you are a woman who can have children, you need to use a very effective form of birth control for at least 1 month before the study starts and continue using it during the study and for one week after it ends. Please note that while electroconvulsive therapy (ECT) is safe for pregnant women with depression, the effects of transcranial magnetic stimulation (TMS) on a fetus are still unknown.

Exclusion Criteria

Known allergic reactions to components of anaesthetic or induction agents

I do not have dementia or any illness that affects my brain function.

I have a history of epilepsy or seizures that doctors couldn't explain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either magnetic seizure therapy (MST) or electroconvulsive therapy (ECT) for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ECT
• MST

Trial Overview The study compares Magnetic Seizure Therapy (MST) with Electroconvulsive Therapy (ECT) to see which is more effective for treating Bipolar Depression and Treatment Resistant Depression. It also examines the side effects associated with each treatment method.

Participant Groups

Group I: magnetic seizure therapy (MST) Experimental Treatment 1 Intervention

Group II: electroconvulsive therapy (ECT) Active Control 1 Intervention

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

Approved in European Union as Electroconvulsive therapy for:

• Major depressive disorder
• Mania
• Autism
• Catatonia

Approved in United States as Electroconvulsive therapy for:

• Major depressive disorder
• Mania
• Autism
• Catatonia

Approved in Canada as Electroconvulsive therapy for:

• Major depressive disorder
• Mania
• Autism
• Catatonia

Who Is Running the Clinical Trial?

Edison Leung

Lead Sponsor

Trials

1

Recruited

60+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

Magnetic seizure therapy (MST) successfully treated a case of treatment-resistant depression in a patient with bipolar I disorder, showing promise as an effective alternative to electroconvulsive therapy (ECT).

MST resulted in shorter seizure durations and less cognitive side effects compared to ECT, with the patient recovering to full orientation more quickly, suggesting MST may offer a safer profile for treating severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy of treatment-resistant depression in a patient with bipolar disorder. Kayser, S., Bewernick, B., Axmacher, N., et al.[2009]

Magnetic seizure therapy (MST) shows no clear differences in effectiveness compared to electroconvulsive therapy (ECT) for treating treatment-resistant depression (TRD), based on a systematic review of three studies involving 65 participants.

The evidence regarding MST's impact on cognitive function, quality of life, and dropout rates is also inconclusive, highlighting the need for larger and better-designed trials to assess its true efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy for treatment-resistant depression. Jiang, J., Zhang, C., Li, C., et al.[2022]

Magnetic seizure therapy (MST) is as effective as bifrontal electroconvulsive therapy (ECT) in treating depression, with response rates of 72.2% for MST compared to 81.5% for ECT, indicating it can be a viable alternative.

MST demonstrated significantly fewer cognitive side effects, showing improvements in immediate and delayed memory and attention, along with shorter recovery times for consciousness and orientation compared to ECT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shorter recovery times and better cognitive function-A comparative pilot study of magnetic seizure therapy and electroconvulsive therapy in patients with depressive episodes. Zhang, J., Ren, Y., Jiang, W., et al.[2023]

Magnetic seizure therapy (MST) allows for significantly faster recovery times compared to electroconvulsive therapy (ECT), with patients opening their eyes about 3 minutes after MST versus 6.7 minutes after ECT, indicating a potential advantage in post-treatment recovery.

Both MST and ECT were found to have comparable levels of anaesthetic depth during treatment, but MST patients exhibited higher bispectral index (BIS) values post-seizure, suggesting better overall recovery and less sedation after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral bispectral index monitoring during and after electroconvulsive therapy compared with magnetic seizure therapy for treatment-resistant depression. Soehle, M., Kayser, S., Ellerkmann, RK., et al.[2018]

In a follow-up study of 70 patients with bipolar disorder who received electroconvulsive therapy (ECT), 93% maintained at least a partial therapeutic response for over 90% of the follow-up period, indicating ECT's long-term efficacy for treating severe depression and mixed states.

73% of patients achieved full remission after ECT, but those with mixed episodes and comorbid anxiety disorders experienced higher relapse rates, suggesting that these factors may negatively impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic follow-up in bipolar patients after successful electroconvulsive therapy. Medda, P., Barbuti, M., Novi, M., et al.[2021]

Electroconvulsive therapy (ECT) is being evaluated for safety in patients with depression and multiple sclerosis (MS), but concerns remain about potential neurological deterioration and complications.

A case study highlighted a significant risk, as a patient experienced a grand mal seizure after their 14th ECT treatment, raising questions about the safety of this intervention in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy in patient with psychotic depression and multiple sclerosis. Urban-Kowalczyk, M., Rudecki, T., Wróblewski, D., et al.[2014]

Electroconvulsive therapy (ECT) is a safe and effective treatment for severe mental disorders when conducted with proper monitoring.

Common side effects of ECT include anterograde amnesia, post-ictal confusion, and physical discomforts like nausea and headaches, but these are generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RECURRENT SELF-LIMITED HYPERTHERMIA FOLLOWING ELECTROCONVULSIVE THERAPY. Sánchez-Morla, EM., Gómez de Las Heras, V.[2023]

Electroconvulsive therapy (ECT) is generally a safe and effective treatment for psychiatric disorders, but it can lead to rare complications such as prolonged seizures, as demonstrated in a case involving an 83-year-old female patient.

In this case, the patient experienced a prolonged seizure lasting about 700 seconds during her third ECT session, highlighting the need for careful monitoring and the development of preventive protocols to manage such risks in future ECT treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epileptic status as a complication of electroconvulsive therapy: a case report. Reyes-Molón, L., Trebbau-López, H., Saiz-González, D.[2012]

Electroconvulsive therapy (ECT) carries several accidental risks, including skin burns and misdelivery of the electrical stimulus, which can affect treatment efficacy and patient safety.

Understanding and preventing these risks is crucial for improving the safety and effectiveness of ECT as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and ECT Stimulus Electrodes: II. Clinical Procedures. Swartz, CM.[2019]

In a study of 621 patients undergoing electroconvulsive therapy (ECT), 21.9% reported headaches and 9% reported myalgia 6 hours after treatment, indicating that headaches are a more common side effect than myalgia.

Headaches were generally mild and decreased in intensity and frequency within 6 hours post-ECT, while myalgia showed a decrease in frequency but not in intensity, suggesting that while side effects occur, they are often tolerable and transient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence and Predictors of Headache and Myalgia in Patients After Electroconvulsive Therapy (ECT). Haghighi, M., Sedighinejad, A., Naderi Nabi, B., et al.[2020]

Magnetic seizure therapy (MST) can induce acute manic symptoms in patients with major depressive episodes, as demonstrated in two cases during an ongoing study of treatment-resistant depression.

Both patients experienced mania after several MST treatments, but their symptoms resolved quickly with medication after stopping the therapy, highlighting the need to monitor for mood changes as a potential side effect of MST.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy-induced mania: a report of 2 cases. Noda, Y., Daskalakis, ZJ., Fitzgerald, PB., et al.[2015]

Magnetic seizure therapy (MST) shows significant antidepressant effects in mood disorders, with remission rates between 30% and 40%, based on a review of 8 clinical studies.

MST appears to have a better cognitive safety profile compared to electroconvulsive therapy (ECT), with no significant cognitive side effects reported, making it a promising alternative for treating major depressive disorder and bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Seizure Therapy for Unipolar and Bipolar Depression: A Systematic Review. Cretaz, E., Brunoni, AR., Lafer, B.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy of treatment-resistant depression in a patient with bipolar disorder. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy for treatment-resistant depression. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Shorter recovery times and better cognitive function-A comparative pilot study of magnetic seizure therapy and electroconvulsive therapy in patients with depressive episodes. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Bilateral bispectral index monitoring during and after electroconvulsive therapy compared with magnetic seizure therapy for treatment-resistant depression. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Naturalistic follow-up in bipolar patients after successful electroconvulsive therapy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Electroconvulsive therapy in patient with psychotic depression and multiple sclerosis. [2014]

7. Spain pubmed.ncbi.nlm.nih.gov

RECURRENT SELF-LIMITED HYPERTHERMIA FOLLOWING ELECTROCONVULSIVE THERAPY. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Epileptic status as a complication of electroconvulsive therapy: a case report. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and ECT Stimulus Electrodes: II. Clinical Procedures. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Incidence and Predictors of Headache and Myalgia in Patients After Electroconvulsive Therapy (ECT). [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Magnetic seizure therapy-induced mania: a report of 2 cases. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Magnetic Seizure Therapy for Unipolar and Bipolar Depression: A Systematic Review. [2018]