PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with PTSD through a structured clinical interview based on DSM-5 criteria
• People whose PTSD symptom severity score on a standard assessment (called the CAPS-5) is 35 or higher
• People between the ages of 18 and 70 years old
• People who have current PTSD symptoms and are either not taking any medication for PTSD, or have been on a stable PTSD medication for at least 3 months
• People who agree not to start or change any other regular medications that, in the treating clinician's opinion, could affect the study results (such as antidepressants, anti-seizure medications, or certain heart medications)
• People who agree to use the nVNS device as instructed and follow all study requirements, including attending follow-up visits
• People who are able to give written consent to participate in the study
• People who already have a primary mental health clinician (such as a psychiatrist, therapist, psychologist, or nurse practitioner) responsible for their psychiatric care before, during, and after the trial

Who may not be able to join:

• People with a psychiatric, cognitive, or behavioural condition that, in the clinician's opinion, could interfere with the study — including those assessed as having a risk of suicidal or homicidal thoughts or behaviour
• People with a significant medical or neurological condition identified through physical examination or blood/urine tests that, in the investigator's opinion, could interfere with the study (such as serious heart, liver, kidney, or nervous system conditions)
• People who have had a cervical vagotomy (a surgical procedure cutting a nerve in the neck) or have a structural abnormality at the device treatment site on the neck (such as swollen lymph nodes, previous neck surgery, or unusual anatomy)
• People who have pain or abnormal sensations at the treatment site on the neck
• People who currently have an implanted electrical or neurostimulation device (such as a pacemaker, defibrillator, deep brain stimulator, cochlear implant, or similar device)
• People who are pregnant, planning to become pregnant during the study, or who are of childbearing potential and are unwilling to use an accepted form of contraception
• People whose ability to give informed consent, attend follow-up visits, or complete self-assessments may be compromised — for example, people experiencing homelessness, people with a developmental disability, or people who are incarcerated
• People who have received a stellate ganglion block (an injection procedure in the neck) (confirm with trial site)
• People who are employed by the investigator or the clinical study site
• People who have used certain fast-acting antidepressant treatments (such as ketamine, esketamine, or electroconvulsive therapy) or non-invasive brain stimulation therapies (such as TMS or transcranial focused ultrasound) within the past 4 weeks, or are currently using them

Important: Always verify eligibility with the trial site directly before applying.