Non Invasive Brain Stimulation for PTSD
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is designed to identify changes in the brain that underlie symptoms of
      combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild
      electrical stimulation to the side of the head (using a method called tDCS) in an attempt to
      reduce the symptoms of PTSD.
    

Detailed description: 
      Being involved in combat is a horrific experience that substantially increases the risk of
      developing posttraumatic stress disorder (PTSD). Although several effective treatments have
      been identified for PTSD a substantial number of patients (up to 50%) continue to experience
      symptoms. The field of neuroscience has revealed that patients with PTSD demonstrate altered
      functioning within, and interactions between, several brain regions; findings that are
      consistent with animal models of chronic stress. Despite this evidence, existing treatments
      are generally not designed using this neuroanatomical knowledge. The central premise of the
      proposed study is that neuroscientifically-based information can be used to develop more
      precise and effective treatments. Transcranial direct current stimulation (tDCS) will be used
      in an attempt to "correct" the dysfunctional brain regions (and communication between these
      regions), with the expectation that this modulation will result in symptom improvement.

      The primary goals of the study are to verify the maladaptive brain networks and then
      establish evidence that tDCS modulates these networks. Subsequent studies, performed during
      the later study years, will examine dose-response relationships and synergistic effects of
      tDCS and existing treatments. Outcome will be assessed using a multi-method approach that
      includes functional connectivity using resting-state functional magnetic resonance imaging
      data, neuropsychological tests, and self-report measures of emotional functioning. The
      combined results will provide vital methodological, mechanistic, and practical information
      necessary for a formal clinical trial of tDCS in PTSD.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Participants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours.; Participants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours.
Other intervention name(s): mild brain stimulation; HD-tDCS; fake tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment