The protocol involves functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy 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.
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 and proton Magnetic Resonance Spectroscopy. Following screening visits, study procedures include two visits, at least two weeks apart, during which subjects will complete brief mood scales, undergo 15 minutes of imaging, receive 20 minutes of Low Field Magnetic Stimulation treatment, and then return to the scanner to undergo another 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 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.
| Condition | Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder |
|---|---|
| Treatment | Low Field Magnetic Stimulation |
| Clinical Study Identifier | NCT03484494 |
| Sponsor | Mclean Hospital |
| Last Modified on | 18 August 2022 |
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