Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression
NCT ID: NCT01929681
Last Updated: 2017-09-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2013-07-31
2016-04-30
Brief Summary
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To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation (LFMS)in subjects with bipolar depression.
Hypotheses:
Investigators expect subjects who receive LFMS to show significant mood improvement one week after the start of a three day course of daily stimulation as compared to subjects who receive sham LFMS.
Investigators expect subjects who receive LFMS to show immediate mood improvement over the first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.
Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.
Detailed Description
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LFMS is unique because of its low electric field strength, and because of its high frequency operation, compared to other electromagnetic treatments. While other treatments such as Electroconvulsive Therapy (ECT) use electric fields equivalent to \> 100-200 Volts/meter to affect the brain, LFMS uses \<1 V/m. Such a low electric field strength indicates that another mechanism is activated by LFMS, and this provides a possibility for a new treatment. It may also give insight into causes of depression.
LFMS is also unique because it has an immediate effect. This immediate effect may have implications for emergency treatment.
The purpose of this study is to observe the response to LFMS in depressed BPD subjects with the aim of assessing the effects of multiple treatments, and of observing the duration of the mood improvement.To do so, the investigators propose to study 72 subjects in a protocol of three treatments in three days. Subjects will be rated before and after each treatment, and will return for mood ratings at one week after treatment. Investigators hope that this characterization of LFMS will allow clinical research groups to perform large trials and to evaluate its clinical effectiveness in patient populations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LFMS - active treatment
Low Field Magnetic Stimulation (LFMS) active treatment
Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.
Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
LFMS - sham treatment
Low Field Magnetic Stimulation - sham treatment
Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.
Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Interventions
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Low Field Magnetic Stimulation
Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must not have serious physical illnesses, neurological diseases or dementias.
3. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II and meet criteria for current depression (DSM-IV major depressive episode, current).
4. Subject must have a MADRS \>= 20, Young Mania Rating Score (YMRS score) \< 7.
5. Subjects must be capable of providing informed consent.
6. Subjects must have an established residence and phone.
7. Subjects may be medicated or unmedicated.
Exclusion Criteria
2. Pregnant or planning on becoming pregnant.
3. 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).
4. Mania, hypomania or mixed mood state.
5. Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
6. Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
7. History of schizophrenia, schizoaffective, obsessive-compulsive or post-traumatic stress disorders.
8. Treatment resistant depression (as determined by the study psychiatrist; consistently and substantially symptomatic over several years despite electroconvulsive therapy, 2 or more adequate trials of a primary mood stabilizer with antidepressant effects (e.g., lithium, valproate or lamotrigine) or antidepressant medications (e.g., bupropion, Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI).)
9. Contraindications for Magnetic Resonance Imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
21 Years
65 Years
ALL
No
Sponsors
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The Depressive and Bipolar Disorder Alternative Treatment Foundation
OTHER
Mclean Hospital
OTHER
Responsible Party
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Michael Rohan
Imaging Physicist
Principal Investigators
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Michael L Rohan, PhD
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
Locations
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McLean Hospital
Belmont, Massachusetts, United States
Countries
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Other Identifiers
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2012P002380
Identifier Type: -
Identifier Source: org_study_id