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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active first | Other | Subjects receive active Low Field Magnetic Stimulation in the first imaging visit and sham in the second. |
|
| Sham first | Other | Subjects receive sham Low Field Magnetic Stimulation in the first imaging visit and active in the second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Field Magnetic Stimulation | Device | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Harper, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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This is a sham controlled, randomized, double blinded crossover design study of immediate change to brain activity caused by Low Field Magnetic Stimulation.
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The device is operated using subject-specific links on a laptop. The active or sham identity of the links is prepared automatically and not known to study staff or participants.