Low Field Magnetic Stimulation for Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      This is a double-blind, randomized, sham-controlled phase II study of the effects of Low
      Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major
      Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind
      treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting
      state fMRI will be performed at baseline and following the third and final treatment session.
    

Detailed description: 
      A minimum of 60 subjects will enter the double-blind treatment phase of the study. This trial
      will be conducted according to the U.S. Food and Drug Administration guidelines and the
      Declaration of Helsinki. Written informed consent will be obtained from all patients before
      protocol-specified procedures are carried out. The subjects will be drawn from an outpatient
      sample of patients with current Major Depressive Disorder (MDD) diagnosed with the use of the
      Mini International Neuropsychiatric Interview (MINI).

      LFMS will follow a previously published protocol for the treatment of a Major Depressive
      Episode (Rohan et al. 2004). LFMS treatments will be delivered with a prototype LFMS device
      manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance
      spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to
      magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging
      of the brain. Sham LFMS will consist of a three-dimensional spoiled gradient echo sequence of
      the same duration as active LFMS and which provides auditory stimulation indistinguishable
      from active treatment.

      At the beginning of a treatment session, the subject will sit in front of and position his
      head within the open bore of the Tal Medical LFMS device. The device will be pre-programmed
      to deliver active or sham treatment so that the subject, operator, and all investigators are
      blinded to active treatment vs. sham. Immediately before and after each treatment session,
      the PANAS, Ham-D-6, and Visual Analog Mood Scale will be administered and the patient will be
      monitored for any adverse events.

      All participants will undergo two sessions of neuroimaging: On the Friday prior to the first
      treatment session (Day 0) and on the day of the third and final treatment session (Day 7).
      Each session of neuroimaging will be 50 minutes in duration and include three imaging
      modalities: Resting State fMRI (rsfMRI), Arterial Spin Labeling MRI (ASL), and Diffusion
      Tensor Imaging (DTI). In addition, we will obtain high-resolution anatomical volumes (SPGR)
      for each subject for the purpose of transforming each individual's imaging data into a common
      space for group comparisons. Subjects will lie still in the scanner and will be instructed to
      let their mind "wander freely" during the acquisition of the resting state fMRI scan, which
      will last 6 minutes (Anon 2001). They will also be instructed to lie still during the ASL and
      DTI scans (each lasting 8 minutes). In addition, we will obtain a high-resolution T1-weighted
      (MP-RAGE) anatomical scan for co-registration of each individual's imaging data into a common
      space for group statistics..

      Resting state fMRI will be used to measure the functional connectivity within the default
      mode network (DMN) and other circuits that are known to function abnormally in MDD (Greicius
      et al. 2007). ASL will be used to measure the regional blood flow within individual nodes of
      this circuitry, while DTI will measure the structural integrity of the connections between
      nodes. Measurements at baseline will be compared to measurements post-LFMS in both active
      treatment and sham groups.
    

Intervention name(s): Active Low Field Magnetic Stimulation; Sham Low Field Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.; Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment