Symptom-specific TMS Targets for Depression and Anxiety
Condition: Depression; Anxiety; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study aims to compare two different treatment targets for transcranial magnetic
      stimulation, an FDA-approved treatment for major depressive disorder (MDD), in terms of their
      relative efficacy for depression versus anxiety.
    

Detailed description: 
      Transcranial magnetic stimulation (TMS) is a safe, noninvasive FDA-cleared technique that is
      commonly used as a treatment for MDD. It has been shown to focally activate specific brain
      regions that are believed to be underactive in these patients. This study aims to compare two
      different TMS targets in the prefrontal cortex. TMS will be administered within FDA-approved
      guidelines under the supervision of a physician with experience in administering the
      treatment and monitoring for complications.

      This will be a prospective double-blind randomized controlled trial to assess the comparative
      efficacy of two different TMS targets within the prefrontal cortex (PFC). The "dysphoric"
      target in the dorsolateral PFC is believed to be more effective for depression, while the
      "anxiosomatic" target in the dorsomedial PFC is believed to be more effective for anxiety.

      Patients with comorbid depression and anxiety will receive 6 weeks of TMS following standard
      clinical parameters (30 treatments over 6 weeks, 10 Hz frequency, 3000 pulses) with
      MRI-guided neuronavigation. Participants will be randomized to either the dysphoric or
      anxiosomatic target. Both targets are believed to be effective treatments for this patient
      population. Participants and raters will remain blinded to the group assignment. All
      participants will receive resting-state functional MRI scans before and after the course of
      treatment in order to study physiological changes.

      The dysphoric target is expected to induce greater relative improvement in depression, while
      the anxiosomatic target is expected to induce greater relative improvement in anxiety.
    

Intervention name(s): Transcranial magnetic stimulation
Intervention type(s): Procedure
Intervention description(s): Transcranial magnetic stimulation (TMS) is a noninvasive FDA-approved technique that is commonly used as a treatment for depression. It has been shown to focally activate specific brain regions that are believed to be underactive in patients suffering from depression. In this study, TMS will be administered within FDA-approved guidelines under the supervision of a physician with experience in administering the treatment and monitoring for complications.
Other intervention name(s): TMS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group double-blind randomized, controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMS; Transcranial; Neuromodulation; Brain stimulation; Depression; Anxiety