[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594270":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":37,"locations":46,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Liege","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active taVNS","EXPERIMENTAL","Patients will undergo 15 sessions of 30-min active taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home.\n\nTo monitor safety, participants will report any side effects after each session.\n\nTo monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response.\n\nA follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview.",[13],"Device: Active taVNS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham taVNS","SHAM_COMPARATOR","Patients will undergo 15 sessions of 30-min sham taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home.\n\nTo monitor safety, participants will report any side effects after each session.\n\nTo monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response.\n\nA follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview.",[19],"Device: Sham taVNS",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Patients will receive active taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will range from 1 to 3 mA, adjusted to the patient's pain threshold, with a pulse width of 250 μsec and a frequency of 25Hz.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will receive sham taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will be fixed at 100 µA, with a pulse width of 250 μsec and a frequency of 25 Hz.",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Nicolas Lejeune, MD, PhD","NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of Liège","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Aurore Thibaut, PT, PhD","NeuroRecovery Lab, GIGA-Consciousness, GIGA Institute, University of Liège",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Mélanie Louras, MSc","CONTACT","+32479925739","melanie.louras@uliege.be",{"name":35,"role":40,"phone":44,"phoneExt":25,"email":45},"+3243233612","athibaut@uliege.be",[47],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University Hospital of Liège","RECRUITING","Liège","4000","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],5.56749,50.63373,{"lat":58,"lon":57},[61],{"name":31,"role":40,"phone":62,"phoneExt":25,"email":63},"+3243663795","nicolas.lejeune@uliege.be",{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Aurore Thibaut","Principal Investigator",[68],{"name":69,"class":70},"University Hospital Sart Tilman, Liege","UNKNOWN","100594270","transcutaneous-auricular-vagus-nerve-stimulation-for-persistent-post-concussion-symptoms-100594270",false,"NCT07017257","Transcutaneous Auricular Vagus Nerve Stimulation for Persistent Post-concussion Symptoms","Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial","taVNS-PPCS","Inclusion Criteria:\n\n* Age between 18 and 65;\n* Between 4 weeks and 1-year post-diagnosis of a concussion;\n* Score equal or above 16 on the Rivermead Post-Concussion Questionnaire;\n* Intact skin at the electrode site.\n\nExclusion Criteria:\n\n* History of chronic neurological or psychological disorders (still untreated 6 months preceding inclusion);\n* Pregnancy or breastfeeding;\n* Presence of an active implant (e.g., pacemaker, cochlear implant);\n* History of myocardial infarction or cardiac arrhythmia;\n* Excessive alcohol consumption (\\> 14 drinks per week) and\u002For drug (\\> 1x\u002Fweek) use within the past 6 months.","ALL","18 Years","65 Years",{"count":83,"type":84},48,"ESTIMATED","INTERVENTIONAL",[87],"NA","Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, holds promise as a therapeutic option by leveraging the bottom-up modulation of brain activity via the auricular branch of the vagus nerve. This study aims to evaluate the neurophysiological and clinical effects of taVNS on brain activity and symptomatology in patients with PPCS through a randomized, controlled, double-blind trial.",[90],"Persistent Post-concussive Symptoms",[92,93,94,95,96],"Vagus nerve stimulation","Transcutaneous electrical nerve stimulation","Non-invasive brain stimulation","Persistent post-concussive symptoms","High-density EEG","2025-06-03",{"date":99,"type":100},"2025-06-12","ACTUAL",{"date":102,"type":100},"2025-05-28",{"date":104,"type":84},"2027-06",{"name":5,"class":6},1]