A Clinical Trial of Magnetic Stimulation in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether repetitive high field transcranial magnetic
      stimulation of the left or right frontal lobes is beneficial for the treatment of depression
      that is refractory to antidepressant medication.
    

Detailed description: 
      Despite the utility of modern psychotropic medications, depression remains a medical problem
      with major societal impact. Electroconvulsive therapy (ECT) is an effective somatic treatment
      for depression. However, ECT has disadvantages, including risks attendant with general
      anesthesia and significant cognitive side effects (e.g. confusion and memory loss). An
      effective but safer somatic therapy for depression could help many patients.

      The brain can be stimulated non-invasively by using time-varying magnetic fields to induce
      electrical currents within the cerebral cortex, a technique known as transcranial magnetic
      stimulation. Preliminary investigations have provided promising evidence of improved mood
      associated with high frequency repetitive transcranial magnetic stimulation (rTMS) of left
      prefrontal cortex in patients with medication-resistant major depression. However, the role
      of stimulus laterality in the effects of prefrontal rTMS have not been tested systematically.
      Furthermore, previous studies have likely been confounded by inadequate patient blinding and
      by a lack of standardization of psychotropic medication treatment. Therefore, we propose to
      use a carefully controlled clinical trial to directly test the hypothesis that the effects of
      prefrontal rTMS on mood are related to the laterality of magnetic stimulation. We also intend
      to improve blinding in comparison to previous studies by: 1) employing a parallel-group study
      design comparing real and simulated rTMS, as opposed to a crossover study design; 2) using
      specially constructed sham magnetic coils which can be placed directly on the scalp surface,
      to more effectively simulate rTMS; and 3) using trains of weak electrical impulses to
      simulate the cutaneous scalp stimulation associated with rTMS. We will minimize confounding
      effects of medications and antidepressant withdrawal by: 1) requiring that all patients have
      fail a monitored clinical trial of an SSRI or other comparable antidepressant prior to rTMS;
      and 2) continuing pharmacological treatment of depression during the rTMS phase of the trial.
      Demonstration of therapeutic efficacy of rTMS in this rigorously controlled clinical trial
      would provide a foundation for further investigation and development of this novel potential
      treatment modality.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS); Sham rTMS; Repetitive Transcranial Magnetic Stimulator
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): 20 Hz rTMS delivered for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli (25 minutes); 20 Hz sham rTMS delivered to L or R frontal region for 2 seconds (40 stimuli) every 30 seconds for a total of 2000 stimuli; Repetitive Transcranial Magnetic Stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; magnetic stimulation