[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06589362":3,"trial-entities:NCT06589362":88,"trial-summary:NCT06589362":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":75,"overall_officials":83,"references":86,"see_also_links":87},"NCT06589362","STU00221084","Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation","Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation","RECRUITING","2026-08","2025-03","2025-03-25","2024-09-07","Shirley Ryan AbilityLab","OTHER",false,"The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).","Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.",[19],"Traumatic Brain Injury",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Transcutaneous auricular vagus active nerve stimulation","In the active stimulation, two electrodes are placed in the cymba conchae of one of the ears, an area thought to be exclusively innervated by the auricular branch of the vagus nerve.",[34],"Transcutaneous auricular vagus nerve stimulation",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Transcutaneous auricular vagus sham nerve stimulation","In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.",[39],"Sham Transcutaneous auricular vagus nerve stimulation",[41,45],{"measure":42,"description":43,"timeFrame":44},"N-Back Computerized Task","In the n-back task, participants are presented a series of visual stimuli. They are asked for each stimulus whether it matches a stimulus n trials before. For example, in a 2-back task, in which the trials consist of letters, participants have to decide whether the current letter is the same as the letter in trial n - 2. We will use a computerized version of this task.","15 minutes",{"measure":46,"description":47,"timeFrame":48},"Trail Making Test - Parts A & B","Trail Making Part A requires participants to draw a line between circles containing numbers in ascending order (e.g., 1-2- 3...etc.). Part B requires participants to alternate drawing a line between ascending letters and numbers (e.g., 1-A-2-B...etc.). The key measures are the time required to complete and the number of errors made in Part A and Part B. This test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task-switching.","5 minutes",[],"ALL","18 Years","65 Years",{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria:\n\nIn inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years.\n\nAbility to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.\n\nExclusion criteria:\n\nAcute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. Significant gross or fine motor weakness. Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments.\n\nAcute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments.\n\nSeverely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay.\n\nDiagnosis of depression. Active substance abuse.",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":13,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"Chicago","Illinois","60610","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Katy Magee, M.H.S. SLP","CONTACT","312-238-6451","kmagee02@sralab.org",{"lat":73,"lon":74},41.85003,-87.65005,[76,80],{"name":77,"role":69,"phone":78,"email":79},"Shira Cohen-Zimerman, PhD","3122386450","sohenzime@sralab.org",{"name":81,"role":69,"phone":82,"email":71},"Katy Magee, M.H.S","3122386451",[84],{"name":77,"affiliation":13,"role":85},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Traumatic Encephalopathy",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study involving about 60 participants. It compares active tVNS with a sham (inactive) stimulation, with the order of these treatments being varied among participants.","completed","Noninvasive Vagal Nerve Stimulation for Traumatic Brain Injury","This study is looking at whether a device called transcutaneous auricular vagus nerve stimulation (tVNS) can help improve thinking skills in people recovering from a mild to moderate traumatic brain injury (TBI). tVNS uses a device placed on the ear to stimulate a nerve. Researchers want to see if this stimulation, when combined with tasks that challenge your thinking, can help you recover better. You might be able to join if you are 18-65 years old, are currently in inpatient rehabilitation for a recent TBI, can use a keyboard, speak English, and can give your own consent. The study will measure success by looking at how well participants perform on computer tasks and a test called the Trail Making Test. The study is currently recruiting about 60 participants.","Your performance on tasks will be measured at 5 and 15 minutes during the study sessions.",128,"You would participate in two sessions, 2-7 days apart. In each session, you would receive either active or sham stimulation while performing thinking tasks.","Not stated in the trial record.",[],"v2"]