Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, the investigators will examine changes in brain activity from Low Field Magnetic Stimulation in subjects over the age of 50 with bipolar disorder who are currently depressed using functional Magnetic Resonance Imaging. Following screening visits, study procedures include two visits, at least two weeks apart, during which subjects will complete brief mood scales, undergo up to 15 minutes of imaging, receive 20 minutes of Low Field Magnetic Stimulation treatment, and then return to the scanner to undergo up to 15 minutes of imaging procedures. Due to the crossover design, subjects receiving active treatment during the first visit will receive sham treatment during the second visit; subjects receiving sham treatment during the first visit will receive active treatment during the second visit. A follow-up phone call will occur at least two days after each imaging/treatment visit. The main endpoint of this study is the observation of changes in resting state functional Magnetic Resonance Imaging activity in post-treatment acquisitions as compared to pre-treatment acquisitions.

Official Title
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Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

Conditions
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Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder

Intervention / Treatment
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* Device: Low Field Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will have a diagnosis of Bipolar Disorder Type I or II, current episode depressed as measure by a MADRS ≥ 20. Subjects must be maintained on a stable dose of all psychotropic medications for a period of at least two weeks prior to screening. Subjects must be capable of providing informed consent. 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. Exclusion Criteria: Dangerous or active suicidal ideation, as measured by the C-SSRS (see Safety Measures section), and physician evaluation. Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or other psychotic disorders, or dementia. Current mania as defined by a score of ≥ 10 on the Young Mania Rating Scale at screening. Subject has an MMSE score ≤ 24. Subject is pregnant or plans on becoming pregnant. Subject has recent history (within 7 days of screening) of ECT or TMS treatment. Subject has recent history of substance abuse (cannot meet DSM-5 criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use). Subject has any contraindication for MRI (i.e. Presence of a pacemaker, neurostimulator, or metal in head or neck).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a sham controlled, randomized, double blinded crossover design study of immediate change to brain activity caused by Low Field Magnetic Stimulation.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active first<br>Subjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second. | Device: Low Field Magnetic Stimulation<br>* Low Field Magnetic Stimulation is an application of a series of electromagnetic pulses to the brain through a small cylinder that the subject places the top of their head inside.<br>|
| Other: Sham first<br>Subjects receive sham Low Field Magnetic Stimulation in the first imaging visit and active in the second. | Device: Low Field Magnetic Stimulation<br>* Low Field Magnetic Stimulation is an application of a series of electromagnetic pulses to the brain through a small cylinder that the subject places the top of their head inside.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting state brain activity measured by functional Magnetic Resonance Imaging. | Comparison of change in brain activity occurring over the time of treatment, compared between active and sham treatment visits. This is assessed by combining pre and post treatment measures made during active and sham treatment visits using the following formula: (post active treatment - pre active treatment) - ( post sham - pre sham). The brain activity is measured using blood oxygenation level dependent image of brain activity acquired in the resting state using functional Magnetic Resonance Imaging. | Resting state functional Magnetic Resonance Imaging data are acquired 4 times, twice within one hour during imaging visit 1 and twice within one hour during imaging visit 2 which occurs at least two weeks later. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fMRI, Low Field Magnetic Stimulation, MRS, Geriatric, Antidepressant