Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Acacia Clinics
With
ElectroCore INC
Vagus Nerve Society
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
PTSD diagnosis as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD
CAPS-5 score \> or = 35
Between the ages of 18 and 70 years
Has PTSD symptoms and either is not taking PTSD medications or stable on PTSD medications for 3 months.
Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than PTSD that, in the opinion of the clinician may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
Agrees to use nVNS as instructed and follow all of the requirements of the study including Follow-up Visit requirements
Able to provide written informed consent
Must have a primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
You may not be if
Psychiatric or cognitive disorder and/or behavioral problems that, in the opinion of the clinician, may interfere with the study, such as symptoms of suicidal or homicidal risk.
Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG), such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness; which in the opinion of the investigator or industry partner interferes with the study
Cervical vagotomy or structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
Currently implanted with an electrical and/or neurostimulator device (e.g., cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator, occipital nerve stimulator)
Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)
Patients with a stellate ganglion block (SGB)
An employee of the Investigator or the clinical study site
Recent (within 4 weeks) or concurrent use of a rapid-acting antidepressant agent (e.g., ketamine, esketamine, ECT) and/or other non-invasive stimulation therapy (e.g., TMS, transcranial focused ultrasound)
