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New treatment option for PTSD
Official title Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)
ClinicalTrials.gov ID: NCT07523685
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in adults. The vagus nerve connects the brain with many organs and systems in the body and plays a role in regulating stress and emotional responses.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
You likely can't join 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...
- Evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar...
- 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...
- Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
See the full eligibility criteria
- 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...
- 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
- 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)...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Sunnyvale, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sunnyvale, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.