Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      Objectives:

      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: 
      Low Field Magnetic Stimulation is an electromagnetic intervention being investigated at
      McLean Hospital because of its effect on symptoms of depression. It consists of pulsed
      electric fields that are induced remotely in the head by a portable coil. It has been
      observed to have mood elevating effects in depressed patients with Bipolar Disorder (BPD).
      These effects are immediate, occurring upon completion of a 20 minute treatment.

      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.
    

Intervention name(s): Low Field Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
Other intervention name(s): LFMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Low Field Magnetic Stimulation; bipolar; depression; alternative treatment