Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the safety and efficacy of synchronized transcranial
      magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects
      with Major Depressive Disorder. This is a multicenter study in which subjects will be
      randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of
      double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy
      or antidepressant medications during the follow-up phase of the study. Follow-up evaluation
      visits will be conducted during those four weeks, with the frequency of the visits determined
      by the treatment choice during that timeframe.
    

Detailed description: 
      Major Depressive Disorder (MDD) is a mental disorder associated with significant functional
      impairment and disability. Affected individuals present with depressed mood, loss of interest
      or pleasure, feelings of guilt, low self-worth, disturbed sleep or appetite, low energy, and
      poor concentration.

      Psychopharmacological therapy as today's mainstream treatment has revolutionized the clinical
      management for major depressive disorders and has been shown to improve the quality of life
      for many patients. With that, these therapies are not effective for all patients. Results
      released from the Sequenced Treatment Alternatives to Relieve Depression Study (STAR*D),
      conducted by the National Institute of Mental Health (NIMH), show that approximately 30% of
      depressed subjects respond to an SSRI in their first trial, despite adequate dosing and
      duration of treatment. The SSRI antidepressants do have a more favorable side effect profile
      than older medications, but they still may be difficult for some patients to tolerate because
      of gastrointestinal distress, anxiety, insomnia, and sexual dysfunction.

      In addition to the psychopharmacologic treatments for depression, other therapies such as
      electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) have
      been shown to have a therapeutic effect in MDD. ECT induces seizures electrically in
      anesthetized subjects. It is generally safe and effective; however the procedure can have the
      negative side effect of memory loss and confusion. Treatment with repetitive stimulation
      (rTMS) is intended to stimulate groups of cells in areas of the brain linked to MDD. While
      the therapy is non-invasive, it is expensive, involves a complex method for locating the
      point of stimulation in the brain, and has the potential for seizures.

      rTMS uses magnetic pulses which causes neuronal activation of specific areas in the brain. It
      is generally believed that this activation causes resetting of cortical oscillators to create
      a therapeutic effect in MDD. The investigators hypothesize that TMS using low energy,
      sinusoidal magnetic fields synchronized to a patient's individual alpha frequency,(sTMS), can
      also affect neuronal activity leading to a reemergence of intrinsic rhythms and clinical
      improvement in MDD. Preliminary study results using sTMS have shown improvements in
      depressive symptoms with minimal side effects.

      This multicenter study is designed to evaluate the safety and efficacy of sTMS in subjects
      with Major Depressive Disorder. Subjects will be randomized to receive treatment 5 days per
      week for 6 weeks. At the end of Treatment Week 6, subject will have completed the study
      treatments and will be offered open label sTMS therapy or alternate antidepressant treatment
      as clinically indicated. At minimum, subjects will be asked to return for one follow-up visit
      four weeks after their last double-blind treatment (Week 10) for evaluation and study
      completion.
    

Intervention name(s): NEST-1 (NeoSync EEG Synchronized TMS); SHAM
Intervention type(s): Device; Device
Intervention description(s): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.; The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMS,; MDD,; Depression,; sTMS,; NEST,; NeoSync,; EEG,; synchronous,; non-invasive neuromodulation,; transcranial magnetic stimulation,; antidepressant,