rTMS for Emotional Difficulties in Verterans
Condition: Mental Health; Depression; rTMS; Anxiety; PTSD; Psychosocial Impairment
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      Mental illness rarely occurs as a single, easily categorized condition. Instead, multiple
      disorders often co-occur. This complicates the treatment plan for many Veterans, especially
      those suffering the most severe dysfunction. This also means that clinical research aimed at
      one specific disorder may not be optimized to treat the realworld presentation of
      neuropsychiatric illness. The investigators propose in this study to develop a novel,
      non-invasive brain stimulation treatment that would promote rehabilitation for Veterans
      suffering a wide range of emotional difficulties. More specifically, the investigators
      propose to up-regulate the brain circuitry that supports flexible problem solving and
      contending with daily demands. Rather than focusing on reducing the symptoms of a specific
      disorder to reduce the intrusion into daily life, the investigators propose to augment those
      brain circuits that promote adaptive cognition and thus quality of life.
    

Detailed description: 
      The investigators propose that because rTMS to dlPFC is targeting cognitive neurocircuitry
      integral to adaptive cognitive functioning, promoting neuroplasticity in this network with
      rTMS could be more precisely optimized to improve quality of life across psychosocial domains
      and across neuropsychiatric presentations. The investigators postulate that through
      up-regulating cognitive control circuitry with rTMS that an individual would have 1) enhanced
      capacity for successfully contending with the shifting contingencies of daily life and 2)
      improved ability to regulate intrusive affect and impulses. As a function of these processes
      an individual is expected to experience reduced psychosocial impairment. Thus, the
      investigators propose that rather than targeting specific symptom reductions in specific
      disorders, rTMS could be dosed for efficacy in enhancing psychosocial functioning. Such an
      approach has the potential to enhance rehabilitation for far more Veterans suffering a range
      of neuropsychiatric conditions.

      Aim 1. Establish the dose-response curve for improved psychosocial functioning secondary to
      accelerated rTMS in a transdiagnostic anxious and depressed sample of Veterans.

      Aim 2. Establish the safety, feasibility, and acceptability of an accelerated delivery
      schedule of therapeutic rTMS for improved psychosocial functioning in a transdiagnostic
      anxious and depressed sample of Veterans.

      Exploratory Aim 3. Establish whether neurocognitive function demonstrates a dose-response
      function to accelerated rTMS similar to psychosocial functioning in a transdiagnostic anxious
      and depressed sample.

      Note: COVID-19 pandemic put a pause on enrollment.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Veterans will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of transdiagnostic psychosocial impairment. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Depression