Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral
      prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a
      safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the
      large variability in the magnitude of clinical outcomes reported is likely related to the
      current lack of knowledge of ideal side of stimulation (left vs right) and the limited
      precision in the targeting of brain circuits needed to obtain an optimal treatment response.
      In this protocol the investigators will: 1) generate individualized treatment plans based on
      an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based
      connectivity analysis to guide the delivery of adjunct, imaging-based & robotically delivered
      rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program
      providing integrated evidence-based psychotherapy and pharmacological management (Treatment
      as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as
      other indicators of clinical change, to determine whether compared with TAU, addition of
      adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed
      to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the
      potential correlation of connectivity changes with clinical outcomes.
    

Detailed description: 
      The investigators propose a randomized, double-blind, sham-controlled, 20 consecutive day
      trial of adjunct rTMS to the right DLPFC for ADM with PTSD receiving TAU at Laurel Ridge
      Treatment Center (LRTC; San Antonio, TX). Methods: Consenting ADM receiving TAU for PTSD at
      LRTC will be randomized to receive 20 consecutive days of adjunct rTMS according to one of
      these two treatment arms: Arm 1 TAU plus rTMS to the right DLPFC and Arm 2 TAU plus sham
      rTMS. At UTHSCSA's Research Imaging Institute (RII), where all brain imaging will be
      conducted, rTMS treatment plans will be generated based on (pre-treatment) anatomical and
      functional magnetic resonance imaging (fMRI) to guide the optimal robotic positioning of the
      TMS coil to accurately target each subject's DLPFC. Initial diagnostic interview and weekly
      clinical follows ups will be conducted at the LRTC by research clinicians blinded to
      subjects' research group. A comparison of baseline brain connectivity measurements with
      subjects' neuroimaging follow ups conducted at treatment Week 3 will be conducted to identify
      network connectivity changes potentially associated to treatment response.
    

Intervention name(s): Active repetitive transcranial magnetic stimulation; robotic arm; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.; This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.; The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver placebo repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.
Other intervention name(s): rTMS; sham rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment