iTBS Study for Depression (Randomized)
Condition: Executive Dysfunction; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Executive function deficits are common in late life depression (LLD) and are associated with
      resistance to antidepressants, poor quality of life, considerable disability and increased
      suicidal risk. This study uses a novel type of Transcranial Magnetic Stimulation called
      intermittent Theta Burst Stimulation (iTBS). iTBS delivers high frequency (50Hz) magnetic
      pulses in "bursts" of 3 stimuli. It is posited that this intervention induces plasticity in
      the human cortex. Theoretical and empirical evidence from research studies informs that iTBS
      can improve depression and executive deficits, however, this has not been examined in older
      adults.

      This project examines iTBS's ability to improve depression and executive impairment in LLD.
      It also tests the effects of iTBS on brain connectivity within the Cognitive Control Network
      (CCN). This study will enhance understanding of LLD, providing critical pilot data to develop
      future randomized controlled clinical trials.

      Both active and sham interventions are administered sequentially to the left and right
      dorso-lateral prefrontal cortex. The total stimulation time is about 7 minutes. These
      interventions are administered for 6 weeks (Monday-Friday). 20 subjects will be randomized.
      Changes in mood from baseline to the end of study are measured with the Montgomery-Asberg
      Depression Rating Scale. Executive function at baseline and end of study are evaluated with
      the National Institutes of Health Toolbox executive domain battery. Safety assessments
      include: the 21 item Scale for suicidal ideation SSI. The frequency, intensity and burden of
      side effects rating (FIBSER) and the Altman Self Rating Mania scale (ASRM). Ancillary
      depression measures include the Quick Inventory of Depressive Symptoms (QIDS) and the
      Clinical Global Impression of Improvement scale.

      Subjects undergo functional Magnetic Resonance Imaging (fMRI) before and after the study
      interventions to test the effects of iTBS on the brain's functional connectivity.

      This research will provide meaningful information about the effects of iTBS on mood and
      executive function in older adults as well as information regarding its effects on brain
      function. Results of this pilot study will inform a grant submission and allow investigators
      to calculate power for a definitive randomized controlled clinical trial to test the efficacy
      of iTBS versus placebo.
    


Intervention name(s): Intermittent Theta Burst Stimulation; sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Intermittent theta burst stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain for 6 weeks.; Sham stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial testing iTBS versus sham
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; executive dysfunction; transcranial magnetic stimulation; intermittent theta burst stimulation; neuromodulation; older adults; geriatrics