Magnetic Stimulation for Bipolar Depression

(LFMSBioMGeri Trial)

Overseen By Julia G Merrill, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Must be taking: Psychotropic medications

Disqualifiers: Schizophrenia, Dementia, Mania, others

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

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Low Field Magnetic Stimulation, a type of magnetic treatment, affects brain function in older adults with bipolar depression. Participants will receive either the real treatment first and a sham treatment second, or vice versa, to compare effects. It is ideal for those diagnosed with Bipolar Disorder Type I or II who are currently experiencing a depressive episode, have maintained a stable medication dose for at least two weeks, and live within two hours of McLean Hospital. The researchers aim to understand the physiological impact of this magnetic treatment and determine if it could be a helpful option for people with bipolar depression. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for bipolar depression.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current psychotropic medications for at least two weeks before screening.

What prior data suggests that this protocol is safe for geriatric patients with bipolar depression?

Studies have shown that Low Field Magnetic Stimulation (LFMS) is generally safe for treating bipolar depression. Research indicates that similar treatments, such as transcranial magnetic stimulation, are well-tolerated by patients. One study found that these treatments had success rates similar to those for regular depression, suggesting LFMS might be just as safe.

Another study examined low-frequency magnetic stimulation and found it possibly effective, with no major safety concerns reported. Although detailed safety data for LFMS remains limited, its use in depression treatment has not shown significant harmful effects so far. This suggests that LFMS is likely well-tolerated for bipolar depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Low Field Magnetic Stimulation (LFMS) for bipolar depression because it offers a non-invasive approach with the potential for rapid mood improvement. Unlike standard treatments like medications and electroconvulsive therapy (ECT), which can take weeks to show effects, LFMS may deliver quicker results. Additionally, LFMS uses a magnetic field to modulate brain activity, offering an alternative for those who cannot tolerate the side effects of traditional medications. This technique represents a promising new avenue for those seeking faster and more tolerable treatment options for bipolar depression.

What evidence suggests that Low Field Magnetic Stimulation might be an effective treatment for bipolar depression?

Research has shown that Low Field Magnetic Stimulation (LFMS) could help treat bipolar depression. For instance, 23 out of 30 patients with bipolar disorder reported improvement after receiving LFMS. Another study found that three sessions of LFMS improved mood in people with depression unresponsive to other treatments. This trial will compare two treatment sequences: one group will receive active LFMS first and sham second, while the other group will receive sham first and active LFMS second. These findings suggest LFMS might help lift the mood of those with bipolar depression. While more research is needed, the early results are promising. ^{1 6 7 8 9}

Who Is on the Research Team?

David G Harper, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for older adults living near McLean Hospital with Bipolar Disorder Type I or II, currently depressed (MADRS ≥ 20), and stable on medications for at least two weeks. They must be able to consent and not have suicidal thoughts, mania, MRI contraindications, recent ECT/TMS treatment, substance abuse history, or other psychotic disorders/dementia.

Inclusion Criteria

Subjects must permanently reside within a 2-hour drive of McLean Hospital

Subjects must be currently seen by a provider (psychiatrist, therapist, PCP) whose practice is within a 2-hour drive of McLean Hospital

Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measured by a MADRS ≥ 20

Exclusion Criteria

Subject is pregnant or plans on becoming pregnant

Dangerous or active suicidal ideation, as measured by the C-SSRS (see 'Safety Measures' section), and physician evaluation

Subject has an MMSE score ≤ 24

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo functional Magnetic Resonance Imaging and receive Low Field Magnetic Stimulation treatment on two separate visits, with a crossover design for active and sham treatments.

2 weeks

2 visits (in-person)

Follow-up

Participants receive follow-up phone calls to monitor safety and effectiveness after each imaging/treatment visit.

2 days after each treatment visit

2 follow-up calls (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Low Field Magnetic Stimulation

Trial Overview

The study tests the effects of Low Field Magnetic Stimulation on brain function in geriatric patients with bipolar depression using before-and-after brain scans. It's a sham controlled trial where participants are randomly chosen to receive either the real treatment or a placebo.

How Is the Trial Designed?

Group I: Sham first Experimental Treatment 1 Intervention

Subjects receive sham Low Field Magnetic Stimulation in the first imaging visit and active in the second.

Group II: Active first Experimental Treatment 1 Intervention

Subjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second.

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Published Research Related to This Trial

In a study involving 84 subjects with treatment-resistant depression, Low-Field Magnetic Stimulation (LFMS) did not show a significant improvement in mood compared to sham treatment after two and four days of therapy.

While LFMS was generally well tolerated, the results suggest that more intensive or longer-duration treatments may be necessary to observe therapeutic effects, as no substantial differences were found in primary and secondary outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind, proof-of-concept (POC) trial of Low-Field Magnetic Stimulation (LFMS) augmentation of antidepressant therapy in treatment-resistant depression (TRD). Fava, M., Freeman, MP., Flynn, M., et al.[2022]

In a study involving 49 patients with bipolar disorder and treatment-resistant depression, sequential bilateral repetitive transcranial magnetic stimulation (rTMS) did not show a significant difference in reducing depression scores compared to sham stimulation.

The findings suggest that active sequential bilateral rTMS may not be effective for treating bipolar depression, indicating a need for future research to explore unilateral rTMS approaches instead.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A negative double-blind controlled trial of sequential bilateral rTMS in the treatment of bipolar depression. Fitzgerald, PB., Hoy, KE., Elliot, D., et al.[2019]

A case study demonstrated that low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral pre-frontal cortex significantly improved symptoms in a drug-resistant bipolar depression patient over a 3-week treatment period, as measured by multiple depression rating scales.

The patient maintained therapeutic benefits for an additional 6 months with periodic maintenance rTMS sessions, suggesting that rTMS could be an effective treatment option for managing bipolar depression, although further controlled studies are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentative transcranial magnetic stimulation (TMS) combined with brain navigation in drug-resistant rapid cycling bipolar depression: a case report of acute and maintenance efficacy. Dell'osso, B., Altamura, AC.[2009]

In a study involving 30 participants with treatment-resistant major depressive disorder, three 20-minute sessions of low field magnetic stimulation (LFMS) were found to significantly reduce depressive symptoms compared to sham treatment, indicating its potential as a rapid-acting therapy.

The mood-enhancing effects of LFMS were not observed after the first or second session, suggesting that multiple treatments are necessary to achieve significant improvements in mood, highlighting the need for further research on optimal treatment schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind pilot dosing study of low field magnetic stimulation (LFMS) for treatment-resistant depression (TRD). Dubin, MJ., Ilieva, IP., Deng, ZD., et al.[2023]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667174325001727

Efficacy, effectiveness and safety of transcranial magnetic ...

Conclusions. TMS is efficacious and safe in BDep, with response and remission rates on par with unipolar depression. High and low frequency ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7749511/

A retrospective analysis of bipolar depression treated with ...

5. CONCLUSION. Results reported here suggest that TMS for bipolar depression is both more successful and more prone to adverse events than a ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6486658/

A Double-blind pilot dosing study of Low Field Magnetic ...

Conclusions: Three 20-minute LFMS sessions were required for active LFMS to have a mood-enhancing effect for individuals with treatment-resistant depression. As ...

4.

psychiatryonline.org

psychiatryonline.org/doi/full/10.1176/appi.ajp.161.1.93

Low-Field Magnetic Stimulation in Bipolar Depression ...

RESULTS: Mood improvement was reported by 23 of 30 bipolar disorder subjects who received the actual EP-MRSI examination, by three of 10 bipolar disorder ...

5.

nature.com

nature.com/articles/s41386-023-01599-z

Accelerated TMS - moving quickly into the future of ...

Preliminary evidence suggests that a more rapid improvement in depressive symptoms may be achieved with accelerated TMS protocols. However, the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11999845/

Efficacy and safety of low-frequency repetitive transcranial ...

For bipolar depression, a meta-analysis suggested that low-frequency stimulation to the right prefrontal cortex was possibly effective. However, a medium or ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02452892

Low Field Magnetic Stimulation (LFMS) in Subjects With ...

The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients ...

8.

nimh.nih.gov

nimh.nih.gov/news/media/2020/sarah-h-lisanby-transcranial-magnetic-stimulation-safety-and-risk

Sarah H. Lisanby: Transcranial Magnetic Stimulation Safety ...

This is an overview of the safety of TMS in the industry-sponsored Pivotal trial that led to the FDA clearance of TMS. In that Pivotal trial, ...

9.

rally.massgeneralbrigham.org

rally.massgeneralbrigham.org/study/lfms_imaging

Low Field Magnetic Stimulation: Imaging Biomarkers in ...

Low Field Magnetic Stimulation may be an effective treatment for depression in people with Bipolar Disorder. We seek to understand how LFMS may reduce ...