Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in
      major depressive disorder, but the effectiveness is not clear due to stimulated region,
      frequency and intensity of magnet field. Standard TMS techniques only can stimulate
      superficial cortical areas as the electric field decreases rapidly as a function of tissue
      depth，while depression is also interconnected with deeper neuronal regions. Deep-brain
      magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.
      Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have
      particular relevance to the response to antidepressants, and reduction of alpha frequency
      (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and
      low-field magnetic stimulation could improve depressive symptoms.

      The objective of this study is to compare the effectiveness of the two different parameters
      of DMS in the treatment of major depressive disorder. The changes of brain derived
      neurotropic factor (BDNF) are also investigated to make a relevant analysis of the
      improvement of depressive symptoms.
    

Detailed description: 
      The study is designed as randomized, double-blinded, active-controlled trial in major
      depressive disorder.

      Patients will be male or female, 18 to 60 years of age, right-handed, outpatient or inpatient
      status, with diagnosis of major depressive episode (single or recurrent) by DSM-IV. The
      HAMD-17 total score is no less than 18 at enrollment. The patients should be drug free at
      least 30 days before entering the trial. The eligible patients are randomized to one of the
      two treatment groups using a 1:1 ratio for the alpha frequency (high frequency) and 0.5Hz
      (low frequency) groups.

      Throughout the course of the study, DMS sessions are administered by trained physicians for
      20 minutes at a time, with 5 sessions per week, during 6 consecutive weeks. Raters who are
      blinded to the treatment arm perform evaluations. The effective outcome is assessed by the
      HAMD-17 and HAMA every two weeks including randomization. Serum BDNF level are also tested at
      each visits (Week 0, 2, 4 and 6). The safety in this study will be assessed by adverse event
      reporting, clinical laboratory measurements and physical examinations.

      Primary efficacy measure will be assessed based on the decrease of HAMD-17 from randomization
      to endpoint (Week 6).
    

Intervention name(s): High frequency stimulation; Low frequency stimulation
Intervention type(s): Device; Device
Intervention description(s): The parameter of DMS: alpha frequency; The parameter of DMS: 0.5Hz
Other intervention name(s): Alpha frequency stimulation; 0.5Hz stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep-brain magnetic stimulation; Brain derived neurotropic factor; Effectiveness; Safety