[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06028477":3,"trial-entities:NCT06028477":84,"trial-summary:NCT06028477":87},{"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":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":14,"eligibility_criteria":44,"std_ages":57,"locations":60,"central_contacts":69,"overall_officials":78,"references":82,"see_also_links":83},"NCT06028477","71954","Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study","NOT_YET_RECRUITING","2027-03-01","2024-08","2024-08-19","2025-01-10","Stanford University","OTHER",false,"The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and\u002For deep brain stimulation. Patients will be followed for 14 months.","The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.",[18],"Parkinson Disease",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},34,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Stanford Glove","The non-invasive neuromodulation hardware system comprises two wireless controllers\u002Fbattery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.",[33,34],"Active stimulation","Sham Stimulation",[36],{"measure":37,"description":38,"timeFrame":39},"Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score","Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.\n\nMinimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment\n\nLower scores indicate greater functionality and higher scores indicate severe impairment in functionality.","Baseline and month 6",[],"ALL","18 Years","92 Years",{"inclusion":45,"exclusion":50,"raw_text":56},[46,47,48,49],"Diagnosed with idiopathic Parkinson's Disease","Fluent in English","Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.","Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.",[51,52,53,54,55],"Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.","Pregnancy, breast-feeding or wanting to become pregnant","Physical limitations unrelated to PD that would affect motor ratings","Has implantation of a medical device","Sensory abnormalities of the fingertips","Inclusion Criteria:\n\nAges 18 or older\n\n* Diagnosed with idiopathic Parkinson's Disease\n* Fluent in English\n* Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.\n* Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.\n\nExclusion Criteria:\n\n* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.\n* Pregnancy, breast-feeding or wanting to become pregnant\n* Physical limitations unrelated to PD that would affect motor ratings\n* Has implantation of a medical device\n* Sensory abnormalities of the fingertips",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":12,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"Stanford","California","94305","United States",{"lat":67,"lon":68},37.42411,-122.16608,[70,75],{"name":71,"role":72,"phone":73,"email":74},"Jessica Yankulova","CONTACT","650-474-9547","jessky@stanford.edu",{"name":76,"role":72,"email":77},"Ellyn Daly","ellynd@stanford.edu",[79],{"name":80,"affiliation":12,"role":81},"Vivek P Buch, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":86},[18],[],{"nct_id":4,"found":88,"summary":89,"prompt_version":99},true,{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an interventional study planning to enroll 34 participants. The study will test the effects of vibrotactile coordinated reset stimulation.","completed","Vibrotactile Coordinated Reset for Parkinson's Disease","This study is exploring a new approach called Vibrotactile Coordinated Reset (vCR) stimulation for people with Parkinson's disease. This treatment uses a device called the Stanford Glove, which delivers gentle vibrations to your fingertips. The goal is to see if vCR can help improve Parkinson's symptoms, potentially offering an alternative to common treatments like Levodopa or deep brain stimulation. You might be able to join if you are 18 or older, have been diagnosed with Parkinson's, speak English, and have a certain score on a Parkinson's motor test (UPDRS III of at least 30). The study will measure success by looking at changes in your Parkinson's symptoms after 6 months. The current recruitment status is unclear.","Participants will be followed for 14 months after the start of the study.",116,"You would be followed for 14 months, with your Parkinson's symptoms assessed at the beginning and at 6 months.","Not stated in the trial record.",[30],"v2"]