[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07689773":3,"trial-entities:NCT07689773":115,"trial-summary:NCT07689773":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":59,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":14,"eligibility_criteria":75,"std_ages":93,"locations":96,"central_contacts":111,"overall_officials":112,"references":113,"see_also_links":114},"NCT07689773","Pro00151125","Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT): Open Label","NOT_YET_RECRUITING","2028-06-30","2026-07","2026-07-09","2026-07-08","Medical University of South Carolina","OTHER",false,"Smell dysfunction significantly impacts quality of life and safety, with limited effective treatments. This open-label study evaluates the preliminary efficacy of combining non-invasive trigeminal nerve stimulation (TNS) with standard smell training (ST) to improve olfactory function. Participants will complete 8 weeks of at-home treatment and attend three in-person visits for assessment. Improvements in smell, mood, sleep, and quality of life will be measured.","Smell dysfunction is a serious health issue associated with everyday dangers like the inability to correctly identify nearby hazards (e.g. burning, gas leaks, or spoiled food), psychosocial problems including social withdrawal and reduced quality and enjoyment of life, a myriad of psychiatric conditions, and a generally increased risk of mortality. Further escalating the gravity of olfactory dysfunction is mounting evidence of olfactory disturbance as prodromal to neurodegenerative disorder.\n\nSmell\u002Folfactory training (ST) has emerged as the first-line, and only (current) treatment for smell loss (SL). Classic ST requires twice daily practice of sniffing odorants over the course of 3 months to regenerate olfactory neurons, engage smell-related cognitive functions, and retrain the brain to smell. ST is promising as a stand-alone treatment for SL. However, limitations of ST include the burden of many months of daily practice that leads to sub-optimal compliance, dropout and modest effect sizes. Methods to accelerate and enhance the benefits of ST are needed.\n\nThe olfactory and intranasal trigeminal circuits are structurally and functionally coupled brain systems, both essential to smell function. In fact, there is widespread central overlap and convergence of these systems that is believed to underlie the strong mutual, inhibitory influence between the odor-processing functions of the olfactory pathway and the pungency-processing functions of the trigeminal pathway. Given the convergence and functional influence the circuits have on one another, it is likely that the trigeminal system can be leveraged to activate or enhance olfaction. As such, a method that directly engages the intranasal trigeminal system may be an effective strategy to improve olfactory function.\n\nTrigeminal nerve stimulation (TNS) is a non-invasive, pain-free, method of neuromodulation that delivers low levels of electrical stimulation to the trigeminal circuit, having potential to enhance smell function through activation of the highly connected olfactory-intranasal trigeminal systems. The study investigator's previously published work demonstrated TNS-enhanced psychophysical detection of odorants in healthy adults. The TNS device is FDA 510(k)-cleared for the at-home treatment of pain and attention deficit hyperactivity disorder (ADHD); however, its use in this study is to enhance olfactory function.\n\nFor this study, the study investigators will conduct an at-home, open label trial of TNS-enhanced ST in adults. The primary objectives are to determine initial efficacy of TNS-enhanced ST at treating smell loss. Objectives will be achieved through the following aims:\n\nAim 1: Determine the effects of TNS-enhanced ST on olfactory deficits. The study investigators hypothesize that 8 weeks of TNS-enhanced ST will show significant improvement in psychophysical and subjective olfactory function at 8 weeks compared to baseline.\n\nAim 2: Determine if TNS-enhanced ST improve other symptoms associated with smell loss. The study investigators hypothesize that 8 weeks of TNS-enhanced ST will show significant improvement in mood, sleep and quality of life at 8 weeks compared to baseline.",[18],"Olfactory Impairment",[20,21,22,23,24,25,26,27],"olfaction","smell loss","chronic rhinosinusitis","olfactory dysfunction","smell training","olfactory training","trigeminal nerve stimulation","sensory loss","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},60,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"COMBINATION_PRODUCT","Trigeminal Nerve Stimulation-enhanced Smell Training","TNS is a form of cranial nerve stimulation that uses a simple transcutaneous electrical nerve stimulation device, and adhesive electrodes that are attached to forehead to deliver low-level electrical current. Stimulating the trigeminal nerve activates the trigeminal afferent sensory pathway and central brain regions where the intranasal trigeminal and olfactory circuits converge. Smell Training requires 4 odors to be smelled individually for 10 sec each and record ratings.",[41],"Open Label Trigeminal Nerve Stimulation-enhanced Smell Training (TNS-enhanced ST)",[43,47,50,53,56],{"measure":44,"description":45,"timeFrame":46},"Change in Psychophysical Olfactory Function from Baseline to 4 and 8 Weeks","Sniffin' Sticks (Bughardt Messtechnik, Wedel Germany) will be used to determine odor threshold (T), odor discrimination (D), and odor identification (I), each on 16-point scales, and summed for a total TDI score. Higher scores indicate better function.","8 weeks",{"measure":48,"description":49,"timeFrame":46},"Change in Perceived Intensity of Odorants from Baseline to 4 and 8 Weeks","Perceived intensity on 100-mm visual analog scales with anchor points: 0=\"imperceptible\" to 100=\"extremely intense\".",{"measure":51,"description":52,"timeFrame":46},"Change in Perceived Hedonics of Odorants from Baseline to 4 and 8 Weeks","Perceived hedonics on 100-mm visual analog scales with anchor points: 0=\"extremely unpleasant\" to 100=\"extremely pleasant\".",{"measure":54,"description":55,"timeFrame":46},"Change in Olfactory-related Quality of Life from Baseline to 4 and 8 Weeks","The Modified Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) consists of 17 negative statements (rated on a scale from 0 to 3; total score ranging from 0 to 51), with lower scores indicating better olfactory-related quality of life.",{"measure":57,"description":58,"timeFrame":46},"Change in Impact of Olfactory Loss from Baseline to 4 and 8 Weeks","The Impact of Olfactory Loss Visual Analog Scale (IOL-VAS) consists of 9 separate items assessing the impact of olfactory loss upon mood, food enjoyment, social interactions, safety, hygiene, sex, cooking, appetite, and weight changes, rated from 0 (no impact) to 10 (biggest impact possible).",[60,63,66,69],{"measure":61,"description":62,"timeFrame":46},"Change in Mood State from Baseline to 4 and 8 Weeks","The Profile of Mood States Short Form (POMS-SF) is a psychological rating scale used to assess transient, distinct mood states across six different dimensions including Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, and Confusion or Bewilderment.",{"measure":64,"description":65,"timeFrame":46},"Change in Sleep Quality from Baseline to 4 and 8 Weeks","The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Scores greater than 5 are indicative of a sleep disturbance.",{"measure":67,"description":68,"timeFrame":46},"Change in Symptoms of Depression from Baseline to 4 and 8 Weeks","The Patient Health Questionnaire-9 (PHQ-9) is a self-administered 9-item questionnaire to screen for the presence and severity of depression. Items are rated on a 3pt scale ranging from 0=\"Not at all\" to 3=\"Nearly every day\". Total score ranges from 0-27 and is used to classify depression severity: 0-4=None\u002FMinimal; 5-9=Mild; 10-14=Moderate; 15-19=Moderately Severe; 20-27=Severe.",{"measure":70,"description":71,"timeFrame":46},"Change in Symptoms of Anxiety from Baseline to 4 and 8 Weeks","The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire to screen for presence and severity of anxiety disorder. Items are rated on a 3pt scale ranging from 0=\"Not at all\" to 3=\"Nearly every day\". Total score ranges from 0 to 21 and is used to classify anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), 15-21 (severe anxiety).","ALL","18 Years","80 Years",{"inclusion":76,"exclusion":82,"raw_text":92},[77,78,79,80,81],"Age 18-80","Self-reported or medically documented smell loss","Treatment-seeking for their smell loss","Naïve to TNS","Able to comprehend English and provide informed consent",[83,84,85,86,87,88,89,90,91],"Medical Records not available to confirm eligibility","Documented\u002FSuspected head injury (e.g. sport, accident, blast exposure)","Neurological disorder (e.g. epilepsy, neurodegenerative disorder)","Serious mental illness (e.g. schizophrenia, bipolar disorder)","Suicidal ideation within the last month","Current (≤6 months) and\u002For heavy cigarette smokers (i.e. ≥ 10 pack-years)","Oral\u002Fnasal steroids or other intranasal medications","Immunomodulatory medications","Pregnant or trying to become pregnant","Inclusion Criteria:\n\n* Age 18-80\n* Self-reported or medically documented smell loss\n* Treatment-seeking for their smell loss\n* Naïve to TNS\n* Able to comprehend English and provide informed consent\n\nExclusion Criteria:\n\n* Medical Records not available to confirm eligibility\n* Documented\u002FSuspected head injury (e.g. sport, accident, blast exposure)\n* Neurological disorder (e.g. epilepsy, neurodegenerative disorder)\n* Serious mental illness (e.g. schizophrenia, bipolar disorder)\n* Suicidal ideation within the last month\n* Current (≤6 months) and\u002For heavy cigarette smokers (i.e. ≥ 10 pack-years)\n* Oral\u002Fnasal steroids or other intranasal medications\n* Immunomodulatory medications\n* Pregnant or trying to become pregnant",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":12,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Charleston","South Carolina","29425","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Bernadette Cortese, Ph.D.","CONTACT","843-792-6922","corteseb@musc.edu",{"lat":109,"lon":110},32.77632,-79.93275,[],[],[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[18],[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an open-label study, meaning both you and the researchers will know what treatment you are receiving. It plans to enroll 60 participants.","completed","Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT)","This study is looking at a new way to help people with smell loss (olfactory impairment). It combines standard smell training with Trigeminal Nerve Stimulation (TNS), which uses a small electrical device on your forehead to stimulate a nerve. The goal is to see if this combination can improve your ability to smell. You might be able to join if you are between 18 and 80 years old, have reported or medically documented smell loss, and are seeking treatment. The study will measure changes in your smell function, how you perceive odors, and how much you enjoy them over 8 weeks. The current status of this study is unclear.","Your smell function and perception will be measured at 4 and 8 weeks after starting the treatment.",109,"You would complete 8 weeks of at-home treatment and attend three in-person visits for assessments.","Not stated in the trial record.",[],"v2"]