[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605771":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":24,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":51,"centralContacts":55,"locations":61,"responsibleParty":80,"collaborators":13,"id":84,"slug":13,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":13,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":13,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":64,"whyStopped":13,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Efficacy of Electrostimulation (ES) Treatment.","To evaluate whether the use of electrostimulation (ES) over a course of 10 treatments (in 8 weeks) will ameliorate symptoms and signs of chronic ocular Graft-vs-Host Disease (oGVHD) and the effect on sub-basal corneal nerve regeneration.","8 Weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":20,"whoMasked":21},"DOUBLE","The principal investigator and the participants will be masked to treatment. The study staff setting up the device will be the only staff who will know the randomization.",[22,23],"PARTICIPANT","INVESTIGATOR","The trial is to test whether transcutaneous electrical stimulation (TES) may be an effective new type of non-invasive treatment for patients who are diagnosed with chronic ocular Graft-vs-Host Disease. Such a treatment can potentially decrease the need for the patients to apply eye drops frequently, repair the damage caused by chronic ocular Graft-vs-Host Disease, and improve the comfort of the eyes naturally.",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Electrostimulation","EXPERIMENTAL","The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude.",[31],"Device: Electrodes with Currents",{"label":33,"type":34,"description":35,"interventionNames":36},"Sham","SHAM_COMPARATOR","The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude.",[37],"Device: Electrodes without Currents",[39,46],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DEVICE","Electrodes with Currents","Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins",[27],[45],"Treatment",{"type":40,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Electrodes without Currents","Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins",[33],[33],[52],{"name":53,"affiliation":5,"role":54},"Zhonghui Luo, MD, PhD","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":13,"email":60},"Michael Cheung, MSc, CCRP","CONTACT","6175736060","mcheung0@meei.harvard.edu",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Massachusetts Eye and Ear - Longwood Campus","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-71.05977,42.35843,{"lat":74,"lon":73},[77,79],{"name":57,"role":58,"phone":78,"phoneExt":13,"email":60},"617-573-6060",{"name":53,"role":54,"phone":13,"phoneExt":13,"email":13},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","Zhonghui K. Luo, MD, PhD","Principal Investigator","100605771",false,"NCT07166848","Electrostimulation Study for Ocular Graft vs. Host Disease","Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease","Inclusion Criteria:\n\n* Diagnosis of chronic ocular graft vs. host disease (oGVHD) (ICCGVHD criteria probable or definite)\n* OSDI score of 22 or higher\n* NEI corneal staining score (or modified NEI score) of 2 or higher.\n\nExclusion Criteria:\n\n* Patients with any open wound on the eyelid.\n* Patient with any active cornea ulcer, dacryocystitis, hordeolum, filamentary keratitis, uveitis, retinal detachment, uncontrolled glaucoma or other active pathology per PI's discretion.\n* Patient with a pacemaker or ICD.\n* Patient currently pregnant or with a potential to be pregnant during the study.\n* Patient undergoing any ocular surgical procedure (including intravitreal injections) within the past 3 months.\n* Patient undergoing any systemic surgical procedures within 2 months.\n* Patient undergoing any non-surgical eyelid procedure such as punctal plugs or punctal cautery within 1 month of study initiation.\n* Patients on cytotoxic agents, drugs that inhibit peripheral nerve regeneration (i.e. Gabapentin, Nicotine), radiation therapy, or any other therapy per PI's discretion.\n* Patients undergoing immunosuppression regimen change within 1 month of study initiation and\u002For during the study period.\n* Patient who wears contact lens of any kind","ALL","18 Years","75 Years",{"count":94,"type":95},15,"ESTIMATED","INTERVENTIONAL",[98],"NA","This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.",[101],"Chronic Ocular Graft-versus-host Disease",[103,27],"GVHD","2025-12-09",{"date":106,"type":107},"2025-12-17","ACTUAL",{"date":109,"type":107},"2025-11-30",{"date":111,"type":95},"2029-11-30",{"name":82,"class":6},1]