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on hold indefinitely due to lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active LFMS treatment | Active Comparator | 20 minute exposure to the LFMS electromagnetic field treatment |
|
| Sham LFMS treatment | Placebo Comparator | 20 minute exposure to either the sham (inactive) electromagnetic field treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Field Magnetic Stimulation Device | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L. Rohan, Ph.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14702256 | Result | Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93. | |
| 15780843 | Result | Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 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 |
| D001519 |
| Behavior |