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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The protocol involves functional Magnetic Resonance Imaging acquisitions immediately before and after Low Field Magnetic Stimulation treatment on two separate days in a sham controlled, randomized trial, in order to assess the physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric population with 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 data supports the effectiveness of the treatment Low Field Magnetic Stimulation for bipolar depression?

Research shows that Low Field Magnetic Stimulation (LFMS) can quickly improve mood in people with bipolar depression, even after just one session. Additionally, similar treatments like transcranial magnetic stimulation (TMS) have shown positive effects in treating bipolar depression, suggesting that LFMS might also be effective. ^{1 2 3 4 5}

Is magnetic stimulation safe for humans?

Research shows that magnetic stimulation, including low field and deep transcranial magnetic stimulation, is generally well-tolerated and safe for humans, with no significant adverse effects reported in studies for bipolar depression and other conditions. ^{1 4 5 6 7}

How does Low Field Magnetic Stimulation (LFMS) differ from other treatments for bipolar depression?

Low Field Magnetic Stimulation (LFMS) is unique because it is a non-invasive treatment that can rapidly improve mood in bipolar depression, often within a single 20-minute session. Unlike traditional medications, LFMS uses magnetic fields to stimulate the brain without the need for drugs, making it a novel option for those who may not respond well to standard treatments. ^{1 3 4 5 8}

Research Team

David G Harper, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States 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). [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A negative double-blind controlled trial of sequential bilateral rTMS in the treatment of bipolar depression. [2019]

3. England 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. [2009]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A double-blind pilot dosing study of low field magnetic stimulation (LFMS) for treatment-resistant depression (TRD). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of Bipolar Depression with Deep TMS: Results from a Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive outcomes of TMS treatment in bipolar depression: Safety data from a randomized controlled trial. [2019]

7. Croatia pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment-Resistant Bipolar Depression. [2022]

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

Rhythmic low-field magnetic stimulation may improve depression by increasing brain-derived neurotrophic factor. [2020]