Magnetic Stimulation for Bipolar Depression
(LFMSBioMGeri Trial)
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.12345
Is magnetic stimulation safe for humans?
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.13458
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants receive follow-up phone calls to monitor safety and effectiveness after each imaging/treatment visit.
Treatment Details
Interventions
- Low Field Magnetic Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor