Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Study Overview
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Brief Summary
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This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.

Detailed Description
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This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a non-significant risk device by the FDA, and there are no known risks associated with its use.

Official Title
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Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

Conditions
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Depression, Bipolar Depression, Major Depressive Disorder

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: Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed May be medicated or unmedicated Exclusion Criteria: Contraindication for MRI due to metal in eyes/head Claustrophobia. Inability to lie flat. History of brain injury. Pregnant Current drug use/abuse/dependence History of polysubstance use

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham (inactive) Treatment BPD<br>20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects | Device: Low Field Magnetic Stimulation Device<br>* The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.<br>* Other names: LFMS;|
| Active Comparator: Active LFMS treatment in BPD<br>20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects | Device: Low Field Magnetic Stimulation Device<br>* The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.<br>* Other names: LFMS;|
| Sham Comparator: Sham LFMS Comparator: in MD<br>20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects | Device: Low Field Magnetic Stimulation Device<br>* The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.<br>* Other names: LFMS;|
| Active Comparator: Experimental LFMS: in MD<br>20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects | Device: Low Field Magnetic Stimulation Device<br>* The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.<br>* Other names: LFMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression | A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression. | Once just before and once just after treatment | 
| Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder | A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression. | Once just before and once just after treatment | 
| Visual Analog Scale (VAS) in Subjects With Bipolar Depression | Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been. | Once just before and once just after treatment | 
| Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder | Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been. | Once just before and once just after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups. | A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression. | Once just before and once just after treatment | 
| Visual Analog Scale (VAS): Combined Diagnostic Groups. | Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been. | Once just before and once just after treatment | 
| Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group. | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. | Once just before and once just after treatment | 
| Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group. | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. | once pre and once post LFMS treatment | 
| Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression. | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. | Once just before and once just after treatment | 
| Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. | Once just before and once just after treatment | 
| Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. | once pre and once post LFMS treatment | 
| Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder | 20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect. | once pre and once post LFMS treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major depression, Bipolar Disorder, Bipolar depression, LFMS, low field magnetic stimulation, mood disorders, affective disorders