Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

Study Overview
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Brief Summary
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To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

Detailed Description
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The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a boost to synapses in certain brain regions. Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.

Official Title
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Low Field Magnetic Stimulation in Mood Disorders in Six Visits

Conditions
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Bipolar Depression, Unipolar Depression

Intervention / Treatment
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* Device: Low Field Magnetic Stimulation Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects MUST be significantly depressed, currently. Subjects must not have serious physical illnesses, neurological diseases or dementias. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed. Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score > 18. Subjects must be capable of providing informed consent. Subjects must have an established residence and phone. Subjects may be medicated or unmedicated. Exclusion Criteria: Dangerous or active suicidal ideation. Pregnant or planning on becoming pregnant. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month). Mixed mood state or rapid cycling. Presence of a pacemaker, neurostimulator, or metal in head or neck.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active LFMS treatment<br>20 minute exposure to the LFMS electromagnetic field treatment | Device: Low Field Magnetic Stimulation Device<br>* The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.<br>* Other names: LFMS;|
| Placebo Comparator: Sham LFMS treatment<br>20 minute exposure to either the sham (inactive) electromagnetic field treatment | Device: Low Field Magnetic Stimulation Device<br>* The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.<br>* Other names: LFMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS)score | MADRS scores will be compared between the baseline and week 3, one week after the final treatment. | at baseline and at week 3 | 
| Change in Positive-Negative Affect Scale (PANAS)score | PANAS scores will be compared between the baseline and week 3, one week after the final treatment. | at baseline and at one and at week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings | PANAS scores will be assessed at baseline and before and after each treatment. There are six treatments (Monday, Wednesday and Friday for two weeks). | at baseline and immediately before and after each treatment, 6 treatments across 2 weeks | 
| Change in Montgomery-Asberg Depression Rating Scale (MADRS)score | MADRS scores will be compared between the baseline and week 4, two weeks after the final treatment. | at baseline and at week 4 | 
| Change in Positive-Negative Affect Scale (PANAS)score. | PANAS scores will be compared between the baseline and week 4, two weeks after the final treatment. | at baseline and at one and at week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Bipolar Depression, LFMS, Electromagnetic Stimulation