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Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD (NCT02769312)

The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.
  • Device: Theta burst stimulation
    Theta burst transcranial magnetic stimulation
    • Device: Sham stimulation
      Sham Theta burst transcranial magnetic stimulation
      Ages eligible for Study
      18 Years to 70 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Diagnosis of chronic PTSD according to DSM-5 criteria
      • Veteran (male or female)
      • age between 18-70 years
      • clinically symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures
      • capable of independently reading and understanding patient information materials and providing informed consent
      Exclusion Criteria:
      • Cardiac pacemaker
      • implanted device (deep brain stimulation) or metal in the brain
      • cervical spinal cord
      • or upper thoracic spinal cord
      • pregnancy/lactation, or planning to become pregnant during the study
      • lifetime history of moderate or severe traumatic brain injury (TBI)
      • current unstable medical conditions
      • current (or past if appropriate) significant neurological disorder, or lifetime history of:
      • seizure disorder
      • primary or secondary CNS tumors
      • stroke
      • cerebral aneurysm
      • primary psychotic disorder
      • bipolar I disorder
      • active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine
      • active suicidal intent or plan
      The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term.

      TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.

      1 locations

      United States (1)
      • Providence VA Medical Center, Providence, RI
        Not specified
        Providence, Rhode Island, United States, 02908
      Status:
      completed
      Type:
      Interventional
      Phase:
      Ⅰ, Ⅱ
      Start:
      31 March, 2016
      Updated:
      01 March, 2018
      Participants:
      55
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