Low Field Magnetic Stimulation Treatment for Bipolar Depression

Study Overview
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Brief Summary
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Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.

Detailed Description
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An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.

Official Title
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Low Field Magnetic Stimulation in Bipolar Depression

Conditions
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Bipolar Depression, Bipolar Disorder, Depression

Intervention / Treatment
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* Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of bipolar disorder. Current depression. Exclusion Criteria: Contraindication for MRI due to metal in eyes/head Claustrophobia. Inability to lie flat. History of brain injury.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active EEP-MRSI treatment<br>20 minutes of active treatment with theEcho-Planar Magnetic Resonance Imaging (EP-MRSI) | Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)<br>* variable-setting low-frequency MRI<br>* Other names: Low Field Magnetic Stimulation (LFMS);|
| Sham Comparator: Sham comparator EP-MRSI<br>Sham treatment (20 minutes) with the Echo-Planar Magnetic Resonance Imaging (EP-MRSI). | Device: Echo-Planar Magnetic Resonance Imaging (EP-MRSI)<br>* variable-setting low-frequency MRI<br>* Other names: Low Field Magnetic Stimulation (LFMS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Affect Scale |  | pre/post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual-Analog Scales |  | pre/post-treatment | 
| Montgomery Asberg Depression Rating Scale (MADRS) |  | pre-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-pharmaceutical, alternative, imaging, magnetic resonance imaging, low field magnetic stimulation, bipolar disorder, depression, bipolar depression