Closed Loop Vagal Nerve Stimulation for Patients With Posttraumatic Stress Disorder
Condition: PostTraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: GammaCore/electroCore non-invasive VNS device; Sham gammaCore/electroCore; O-15 water
Intervention description: Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus (the current amplitude) is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V), the burst frequency to 5 kilohertz (kHz), and the envelope frequency to 25 Hz. These are the standard frequency settings that electroCore has demonstrated to be most effective in capturing the vagus nerve based on evoked potential studies. The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.; Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.; Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2[15O] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2[15O]. Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: stress disorders, post-traumatic; posttraumatic stress disorder; PTSD; vagal nerve

Summary:

      The tasks of the project are to map the potency and kinetics of the neurologic, autonomic
      peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham
      treatment, at baseline and in response to stressful traumatic scripts related to personal
      traumatic events, as well as a series of other stressors.
    

Eligibility criteria:

        Inclusion Criteria:

        Phase 1:

          -  Do not meet criteria for post traumatic stress disorder (PTSD) or other major mental
             disorder as determined by the Structured Clinical Interview for Diagnostic and
             Statistical Manual of Mental Disorders-5 (DSM-5 SCID) interview for PTSD

          -  Have a history of psychological trauma as defined by DSM-5.

        Phase 2:

        - Meet criteria for PTSD as determined by the Structured Clinical Interview for DSM-5
        (SCID) interview for PTSD.

        Exclusion Criteria:

          -  Positive pregnancy test

          -  Meningitis

          -  Traumatic brain injury

          -  Neurological disorder or organic mental disorder

          -  History of loss of consciousness greater than one minute

          -  Alcohol abuse or substance abuse or dependence based on the SCID within the past 12
             months

          -  Positive toxicology screen

          -  Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia,
             based on the SCID

          -  A history of serious medical or neurological illness, such as cardiovascular,
             gastrointestinal, hepatic, renal, neurologic or other systemic illness

          -  Evidence of a major medical or neurological illness on physical examination or as a
             result of laboratory studies (complete blood count (CBC), blood urea nitrogen (BUN),
             creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis,
             and EKG)

          -  Active implantable device (i.e. pacemaker)

          -  Carotid atherosclerosis

          -  Cervical vagotomy