[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-stress-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-stress-disorders":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,60,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100633207","non-invasive-vagus-nerve-stimulation-nvns-for-post-traumatic-stress-disorder-ptsd-100633207",false,"NCT07523685","Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)","Non-invasive Vagus Nerve Stimulation (nVNS) for Adjunctive Treatment of Symptoms Associated With Post-Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* PTSD diagnosis as determined by the Structured Clinical Interview for DSM-5 (SCID) interview for PTSD\n* CAPS-5 score \\> or = 35\n* Between the ages of 18 and 70 years\n* Has PTSD symptoms and either is not taking PTSD medications or stable on PTSD medications for 3 months.\n* 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.)\n* Agrees to use nVNS as instructed and follow all of the requirements of the study including Follow-up Visit requirements\n* Able to provide written informed consent\n* Must have a primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n\nExclusion Criteria:\n\n* Psychiatric or cognitive disorder and\u002For behavioral problems that, in the opinion of the clinician, may interfere with the study, such as symptoms of suicidal or homicidal risk.\n* 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\n* Cervical vagotomy or structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)\n* Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)\n* Currently implanted with an electrical and\u002For 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)\n* Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control\n* 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)\n* Patients with a stellate ganglion block (SGB)\n* An employee of the Investigator or the clinical study site\n* Recent (within 4 weeks) or concurrent use of a rapid-acting antidepressant agent (e.g., ketamine, esketamine, ECT) and\u002For other non-invasive stimulation therapy (e.g., TMS, transcranial focused ultrasound)","ALL","18 Years","70 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nThe vagus nerve connects the brain with many organs and systems in the body and plays a role in regulating stress and emotional responses. The gammaCore device is a handheld, rechargeable medical device that delivers gentle electrical stimulation to the vagus nerve through the skin on the side of the neck. By stimulating this nerve, the device may help reduce PTSD symptoms.\n\ngammaCore is cleared by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of migraine and cluster headache. It has not yet been approved for the treatment of PTSD. This study is being conducted to better understand whether this type of stimulation may help improve PTSD symptoms and to evaluate its safety when used for this purpose.\n\nThe main questions this study aims to answer are:\n\n* Is non-invasive vagus nerve stimulation safe for people with PTSD when used regularly at home?\n* Does treatment with the gammaCore device improve PTSD symptom severity over time?\n\nIn this study, approximately 40 adults with PTSD will participate in an open-label pilot study.\n\nParticipants will first complete a 4-week baseline period in which their PTSD symptoms are monitored. This allows researchers to understand each participant's symptoms before starting the intervention.\n\nParticipants will then begin a 12-week treatment period using the gammaCore device at home. During this time, participants will apply the device to the side of the neck for short stimulation sessions each day as instructed by the study team.\n\nParticipants will attend six study visits, some conducted remotely and some in person. These visits include screening, training on how to use the device, and follow-up assessments. During the study, participants will complete questionnaires and clinician-administered assessments that measure PTSD symptoms and quality of life. Researchers will also monitor participants for any side effects or medical problems related to the device.\n\nBy collecting information on symptoms, safety, and device use, this study will help researchers understand whether non-invasive vagus nerve stimulation could become a useful treatment option for people living with PTSD.",[27,28,29,30,31,32,33],"PTSD","Post Traumatic Stress Disorder PTSD","PTSD - Post Traumatic Stress Disorder","Post Traumatic Stress Disorder","Post Traumatic Stress Disorders","Post-traumatic Stress Disorder (PTSD)","Post-Traumatic Stress Disorder, PTSD",[27,35,36,37,38,39,40,41,42,43,44,45,46],"nVNS","Non-invasive","vagus nerve stimulation","vagus nerve stimulator","Post-traumatic stress disorder","neuromodulation","non-invasive vagus nerve stimulation (nVNS)","Adjunctive treatment of post traumatic stress disorder","gammaCore","VNS","peripheral nerve stimulation","brain stimulation","RECRUITING","2026-04-22",{"date":50,"type":51},"2026-04-27","ACTUAL",{"date":53,"type":51},"2026-03-02",{"date":55,"type":21},"2027-03",{"name":57,"class":58},"Acacia Clinics","INDUSTRY",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":59},"100157898","early-phase-1-mental-health-in-veterans-and-families-after-group-therapies-100157898","NCT01327690","Mental Health in Veterans and Families After Group Therapies","Inclusion Criteria:\n\n* The ability to follow instructions, complete written forms, and provide informed consent. Subjects are required to be literate and understand English.\n* Physically healthy.\n* Active duty military service, veterans, and their family members.\n\nExclusion Criteria:\n\n* None",true,"80 Years",{"count":69,"type":21},100,[71],"EARLY_PHASE1","PTSD (posttraumatic stress disorder) and associated mental health conditions affect both veterans and their family members. This study investigates whether group therapy using EFT (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in PTSD and comorbid symptoms.",[74],"Post-Traumatic Stress Disorders",{"date":50,"type":51},{"date":77,"type":51},"2010-12-31",{"date":79,"type":21},"2027-12-31",{"name":81,"class":82},"Soul Medicine Institute","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":59},"100564429","cognitive-control-training-for-extinction-in-ptsd-100564429","NCT06629064","Cognitive Control Training for Extinction in PTSD","Identifying Clinically Relevant Neural Circuit Mechanisms of Cognitive Control Training for PTSD","Inclusion Criteria:\n\n* Fluent in English\n* Meet current DSM-5 criteria for Posttraumatic Stress Disorder\n* Are willing to attend 8 total remote sessions of working memory training over course of four weeks\n* Are willing to attend MRI scans pre and post working memory training\n* 4-week stability on pharmacological and psychosocial treatments\n\nExclusion Criteria:\n\n* A lifetime history of psychotic disorders, lifetime history of bipolar disorder\n* Past-year severe substance use and severe alcohol use disorder. Mild-to-moderate alcohol use disorder will be allowed to enhance generalizability in our sample due to the high comorbidity of alcohol use and PTSD\n* History of any neurological disorder that might be associated with cognitive dysfunction (e.g., cerebrovascular accident, intracranial surgery, aneurysm, seizure disorder)\n* Acute suicidality requiring immediate clinical intervention\n* Moderate to severe traumatic brain injury (TBI). However, mild to moderate levels of TBI (mTBI) will be included.\n* Receiving benzodiazepines or medications with anticholinergic effects that may affect fear learning measures\n* Inability to safely complete fMRI session (i.e., metal in body, medical implants)","65 Years",{"count":92,"type":21},120,[24],"The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.",[74,96,30,27,97],"Stress Disorders, Traumatic","Trauma and Stressor Related Disorders",[97,27,99,100,101],"cognitive training","working memory","Fear Extinction","2025-09-04",{"date":104,"type":51},"2025-09-08",{"date":106,"type":51},"2024-10-01",{"date":108,"type":21},"2028-09-30",{"name":110,"class":111},"VA Office of Research and Development","FED"]